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22–987PDF 2005

LEGISLATION TO REAUTHORIZE THE NATIONAL

INSTITUTES OF HEALTH

HEARING

BEFORE THE

COMMITTEE ON ENERGY AND

COMMERCE

HOUSE OF REPRESENTATIVES

ONE HUNDRED NINTH CONGRESS

FIRST SESSION

JULY 19, 2005

Serial No. 109–40

Printed for the use of the Committee on Energy and Commerce

(

Available via the World Wide Web: http://www.access.gpo.gov/congress/house

COMMITTEE ON ENERGY AND COMMERCE

JOE BARTON, Texas, Chairman

RALPH M. HALL, Texas

MICHAEL BILIRAKIS, Florida

Vice Chairman

FRED UPTON, Michigan

CLIFF STEARNS, Florida

PAUL E. GILLMOR, Ohio

NATHAN DEAL, Georgia

ED WHITFIELD, Kentucky

CHARLIE NORWOOD, Georgia

BARBARA CUBIN, Wyoming

JOHN SHIMKUS, Illinois

HEATHER WILSON, New Mexico

JOHN B. SHADEGG, Arizona

CHARLES W. ‘‘CHIP’’ PICKERING,

Mississippi, Vice Chairman

VITO FOSSELLA, New York

ROY BLUNT, Missouri

STEVE BUYER, Indiana

GEORGE RADANOVICH, California

CHARLES F. BASS, New Hampshire

JOSEPH R. PITTS, Pennsylvania

MARY BONO, California

GREG WALDEN, Oregon

LEE TERRY, Nebraska

MIKE FERGUSON, New Jersey

MIKE ROGERS, Michigan

C.L. ‘‘BUTCH’’ OTTER, Idaho

SUE MYRICK, North Carolina

JOHN SULLIVAN, Oklahoma

TIM MURPHY, Pennsylvania

MICHAEL C. BURGESS, Texas

MARSHA BLACKBURN, Tennessee

JOHN D. DINGELL, Michigan

Ranking Member

HENRY A. WAXMAN, California

EDWARD J. MARKEY, Massachusetts

RICK BOUCHER, Virginia

EDOLPHUS TOWNS, New York

FRANK PALLONE, Jr., New Jersey

SHERROD BROWN, Ohio

BART GORDON, Tennessee

BOBBY L. RUSH, Illinois

ANNA G. ESHOO, California

BART STUPAK, Michigan

ELIOT L. ENGEL, New York

ALBERT R. WYNN, Maryland

GENE GREEN, Texas

TED STRICKLAND, Ohio

DIANA DEGETTE, Colorado

LOIS CAPPS, California

MIKE DOYLE, Pennsylvania

TOM ALLEN, Maine

JIM DAVIS, Florida

JAN SCHAKOWSKY, Illinois

HILDA L. SOLIS, California

CHARLES A. GONZALEZ, Texas

JAY INSLEE, Washington

TAMMY BALDWIN, Wisconsin

MIKE ROSS, Arkansas

BUD ALBRIGHT, Staff Director

DAVID CAVICKE, Deputy Staff Director and General Counsel

REID P.F. STUNTZ, Minority Staff Director and Chief Counsel

(II)

C O N T E N T S

Page

Testimony of:

Zerhouni, Elias A., Director, National Institutes of Health .......................... 10

Additional material submitted for the record:

Zerhouni, Elias A., Director, National Institutes of Health, response for

the record ....................................................................................................... 65

(III)

(1)

LEGISLATION TO REAUTHORIZE THE

NATIONAL INSTITUTES OF HEALTH

TUESDAY, JULY 19, 2005

HOUSE OF REPRESENTATIVES, COMMITTEE ON ENERGY AND COMMERCE, Washington, DC.

The committee met, pursuant to notice, at 2 p.m., in room 2318

of the Rayburn House Office Building, Hon. Nathan Deal (acting

chairman) presiding.

Members present: Representatives Barton, Bilirakis, Deal, Wilson, Buyer, Pitts, Walden, Ferguson, Rogers, Myrick, Murphy, Burgess, Blackburn, Waxman, Markey, Towns, Brown, Rush, Eshoo,

Stupak, Engel, Wynn, Green, DeGette, Capps, Allen, Solis, Inslee,

and Baldwin.

Staff present: Chuck Clapton, chief health counsel; Cheryl Jaeger, majority professional staff; Eugenia Edwards, legislative clerk;

Brandon Clark, health policy coordinator; John Ford, minority

counsel; and Voncille Hines, minority research assistant.

Mr. DEAL. I call this hearing to order. I need to explain to our

witness, and to the rest of the committee that our chairman and

some of our members of this committee are engaged in the Energy

Conference, and therefore, they may come in, and they may have

to leave. So—and the fact that they are meeting right now—we decided to proceed on with this hearing today, and I believe we have

enough to proceed.

I recognize myself for a very brief opening statement. First of all,

I want to welcome Dr. Zerhouni to this hearing, and it is a hearing

in our continuing effort to reauthorize the National Institutes of

Health, and we appreciate you for joining us again, as you have in

the past. This is an area of jurisdiction that is important to this

committee, and many of you are aware that this is actually the

eleventh hearing we have had on NIH in the last 21⁄2 years, and

all of us are hopeful that the result of those hearings and the work

of our staffs will allow us to achieve the very important function

of reauthorizing NIH.

We have been working on the issue of reauthorization of NIH for

longer than many people on this committee have actually been in—

serving in Congress, and some of us are of the opinion that now

is the time to finalize that issue, and we are hopeful of doing that

in the very near future. One of the issues that is important, I

think, to all of us on this committee, regardless of our party affiliation, is the fact that in the absence of reauthorizing NIH, this

committee basically cedes its jurisdiction to another committee,

namely, the Appropriations Committee, and we believe that it is

2

appropriate for us to reclaim that issue of jurisdiction, and this effort to reauthorize will do that.

Times have changed, and certainly, as times change, the necessity of looking at organizations such as NIH, and whether or not

it, too, should change is indeed appropriate. Dr. Zerhouni, again,

we welcome your attendance today, and look forward to hearing

your testimony and working with you as we proceed with NIH reauthorization.

I am now pleased to recognize my ranking member of our subcommittee, but I presume standing in also for the full committee,

Mr. Brown of Ohio.

[The prepared statement of Hon. Nathan Deal follows:]

PREPARED STATEMENT OF HON. NATHAN DEAL, CHAIRMAN, SUBCOMMITTEE ON

HEALTH

Thank you, Mr. Chairman.

I want to start off by welcoming Dr. Zerhouni to this hearing on our efforts to

reauthorize the National Institutes of Health. We appreciate your joining us again

this afternoon to talk about one of the most important priorities under the jurisdiction of this Committee.

As you are well aware, this will be the Energy and Commerce Committee’s eleventh hearing on the NIH in last two and a half years, and we are hopeful we can

all continue to work together to achieve some much-needed improvements to this

vital component of our federal government.

As many of you know, we have been working on reauthorizing the NIH longer

than most of the Members of this Committee have been serving in Congress, and

it is well past time for this Committee to get something done.

Indeed, Mr. Chairman, it is time for Authorizers to be Authorizers again, and I

applaud you for your leadership on this very important issue.

Times change and organizations must adapt to this change. We must modernize

the organizational structure of the NIH so that we can advance scientific discovery

for the benefit of all mankind.

Again, Dr. Zerhouni we appreciate your attendance and expertise, and we look

forward to working with you as we strive to improve one of the most important

agencies in our government.

Mr. BROWN. Thank you, Mr. Chairman, and thank you, Dr.

Zerhouni, as always, for joining us with your wisdom and your

knowledge. It is our responsibility to ensure that agencies under

our jurisdiction have the resources and statutory authority they

need to advance the public good. NIH represents half the discretionary budget at HHS, and the chairman has rightly assigned a

high priority to its reauthorization.

As we know, NIH is a complex agency. Its work affects the lives

of millions of Americans. I want to make it clear that passing a

consensus, a consensus bill, requires that all parties have the necessary time to contribute their ideas, perspective, and insight into

the final product, and I would reiterate, have the necessary time

to contribute these ideas and perspective.

Well, this committee has had numerous hearings on NIH. The

devil, of course, is in the details. Members of Congress and stakeholder groups have had less than a week to review legislation that

translates general concepts into concrete operational changes in a

very complicated structure, as I have seen from both committee

hearings and individual personal conversations with Dr. Zerhouni.

We need time to make sure the bill does what we think it does,

and that those changes are beneficial. However, given the right

timeframe, and with the right input from inside Congress and outVerDate 11-MAY-2000 07:18 Dec 05, 2005 Jkt 000000 PO 00000 Frm 00006 Fmt 6633 Sfmt 6602 22987.TXT HCOM1 PsN: HCOM1
3

side Congress, I am confident we can pass a bill that represents

true progress for NIH and for all of the American public.

Thank you.

Mr. DEAL. Thank the gentleman. Does anyone else wish to make

an opening statement?

Mr. BILIRAKIS. Just a very brief one.

Mr. DEAL. Mr. Bilirakis.

Mr. BILIRAKIS. Just a very brief one, Mr. Chairman.

I am one of those people who will probably have to be called

upon at a moment’s notice to go downstairs for a vote on the conference, but I did want to join you and the others in welcoming Dr.

Zerhouni here, and to thank you for your part in the preparation

of this legislation.

We must reauthorize NIH. I think we all agree to that, to increase transparency and accountability at the agency, and to ensure that it is operating as effectively and efficiently as possible.

And I would also like to say, and really emphasize, Mr. Chairman,

that we must make certain that any changes that we make to NIH

will not harm its various institutes. I am always concerned about

the unintended consequences of our acts. Haste sometimes makes

waste. We are all—have our minds made up that we are going to

reauthorize this time around. We are working with the minority,

which is just great in that regard, but let us make sure that we

are concerned that our—whatever we do do, and whatever changes

we do make will not cause more harm than good.

So having said that, Mr. Chairman, I would yield back, and

thank you.

Mr. DEAL. Thank the gentleman. Anyone else. Mr. Rush?

Mr. RUSH. Thank you, Mr. Chairman. Mr. Chairman, I also want

to thank you for holding this hearing, and I will be brief, since my

time in short, and we want to really get to hear Dr. Zerhouni.

Mr. Chairman, I truly appreciate your leadership in this committee reasserting its jurisdiction over the National Institutes of

Health. For too long, the appropriators have had way too much authority over NIH, and it is time that this committee put an end to

that reign. With all due respect to that other committee, we are the

committee of expertise, and it serves this Congress, the NIH, and

the American people well when we utilize that expertise.

Having that said, I have two key issues that I would like to—

the draft legislation before us to address. First, I remain concerned

that the issue of racial disparities, an old, shameful problem that

has not gone away, and Dr. Zerhouni, in his statement, agrees with

this point, that the issue of racial disparities is not adequately addressed by this bill. We need stronger mandates for our premier

medical research institute to aggressively address an inexcusable

and unconstitutional problem in our country here. Specifically, I

want to hear what NIH can do to include more people of color and

women in clinical trials, both as researchers themselves, and as

subjects in the private sector.

Second, I am concerned that medical research in this country is

not adequately incorporating children in their research and medical

deliberations. I believe that NIH needs to consider the pros and

cons of including children in clinical trials, and use its leverage and

Federal dollars accordingly.

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As always, I welcome the Director to this hearing, and I look forward to his testimony. And Mr. Chairman, I look forward to working with you and the rest of the members of this committee, so that

we can come up with a truly bipartisan, cooperative, and deliberative piece of legislation that reauthorizes the National Institutes of

Health.

I yield back the balance of my time.

Mr. DEAL. Thank the gentleman. I recognize Ms. Wilson for an

opening statement.

Ms. WILSON. Thank you, Mr. Chairman, and thank you for holding this hearing.

I think there are some concepts in this draft legislation that are

worth supporting, certainly in prioritizing the research in the most

promising areas, and allowing greater flexibility to manage research roadmaps across the various institutes of the National Institutes of Health, and second, to give the Director authority over a

certain percentage of funding to direct particular research—and

there is a precedent in this area, with the Department of Energy

Laboratories, where a certain percentage is set aside for lab-directed research and development, to put money toward the most

promising research.

There are a couple of areas I think we need to be attentive to.

One is that this legislation tries to move forward on establishing

an electronic data base of research projects, which is very helpful

to those who are looking for clinical trials, and information about

research ongoing. I think we need to make sure that that data base

is publicly available, not just to people who are researchers or medical doctors, but accessible to the public, who are paying for this

research, that it is searchable, and it really does enhance access to

clinical trials.

The second area where I have some concerns has to do with public/private coordination or collaboration. The legislation does anticipate some partnership in high risk and high reward areas of research, but I wonder whether we should limit those collaborative

mechanisms to just the high risk research, and whether we should

expand those mechanisms and encouragement to include basic research, because there is a lot more research that is done outside

of the NIH than is done inside of the NIH, and collaboration and

coordination could, I think, help both.

And with those two caveats, I look forward to the testimony

today. Thank you, Mr. Chairman.

Mr. DEAL. Thank the gentlelady. Mr. Waxman, do you have an

opening statement?

Mr. WAXMAN. Yes, Mr. Chairman.

The National Institutes of Health is, without doubt, one of the

premiere agencies in the Federal Government. It is widely respected throughout the world. It is an agency with a mission critical to the Nation’s health; and it is an agency that few would dispute is working well.

Can it do better? Of course. Where it can be strengthened, we

want to do that. All of us want to provide the necessary tools to

enhance its ability to perform its mission. But this is not an agency

which is broken. The changes we make to improve it must be

thoughtful and measured, and we must be certain that we are not

5

unintentionally taking actions which reduce the very features that

have made it strong.

Our goal, as authorizers of this institution, should not be to restrict the resources the agency receives, but to provide fully for its

support and growth now and into the future. Our goal should be

to maintain and defend the peer review process which is at the

heart of its strength, and to give the Institutes the tools to stay at

the forefront of medical research.

I look forward to hearing from Dr. Zerhouni today, and from any

other persons and institutions who support and benefit from the

work of this agency. And I hope and trust this committee will move

forward with caution and care and deliberation.

Thank you.

Mr. DEAL. Thank the gentleman. Anyone on this side have—Dr.

Burgess, recognized for an opening statement.

Mr. BURGESS. Thank you, Mr. Chairman, and I, too, appreciate

your holding this hearing today, and I know that this reauthorization is one of your highest priorities, and I think we can see the

fruits of your labor before us today, and of course, welcome again

the Director of the NIH, Dr. Zerhouni, and I am looking forward

to his comments on the draft bill.

On my review, I think the draft does strike a balance of achievable reforms. Granting the Director greater budgetary authority

will go a long way in redirecting research priorities at the NIH.

With additional oversight and authority, the NIH director can plan,

in a more strategic manner, and respond to emergencies as they

occur.

I have visited the NIH. I have visited with the Director, and you

really get a sense of how precious that organization is to this country. In fact, it is my visit to the NIH that is one of the few things

of the last 21⁄2 years that have really made me optimistic about the

future of this country that we are leaving to our children and

grandchildren.

The research conducted by the NIH is truly groundbreaking,

whether it is additional treatment for cancer or a greater understanding of the human genome, the NIH has a proven record of innovation. Improvements can be made in its managerial structure,

and that is, in fact, how we will improve the quality of research

conducted at NIH and the health of all Americans.

Thank you, Mr. Chairman. I will yield back.

Mr. DEAL. Thank the gentleman. Anyone else? Mr. Engel.

Mr. ENGEL. Thank you, Mr. Chairman. At the outset, I would

like to say that I like sitting on this side of the committee. I want

to thank you for——

Mr. DEAL. You have to act accordingly.

Mr. ENGEL. I want to thank you for convening this hearing

today. I am very pleased to welcome Dr. Zerhouni back for his seventh appearance before our committee.

It is always good to see you, Doctor. It is disappointing, though,

that none of the stakeholders that will be affected by the proposed

restructuring of the NIH were invited to give their reaction to

these proposals. I certainly support initiatives to improve coordination and increase transparency among the NIH institutes and centers. The proposed concentration of budget, management, and

6

grant making authority in the office of the NIH, though, may go

further than necessary to achieve these goals.

I am concerned that the discussion draft establishes four specific

authorizations of appropriations line items, which may dramatically impact the ability of the constituencies of the 27 research institutes and centers from having a place at the table in the appropriations process. I am not certain that authorizing the virtual

elimination of these important relationships is the best policy proposal.

I appreciate the commitment of the chairman to open and amend

the proposed legislation based on feedback from members of this

committee and the many stakeholders who work with and benefit

from NIH research. As we move forward, it is my sincere hope that

we can pass legislation that strengthens the management of the

NIH without sacrificing the voices of these important groups.

I thank you, and I yield back.

Mr. DEAL. Thank the gentleman. Mr. Ferguson.

Mr. FERGUSON. Does that mean we have to act accordingly on

this side, Mr. Chairman?

Mr. DEAL. You are excused.

Mr. FERGUSON. Thank you, Mr. Chairman. I certainly thank Dr.

Zerhouni for being here again with us today, and certainly looking

forward to the reauthorization process.

The NIH is a place where groundbreaking research occurs daily,

research that might lead to a cure for many of the diseases that

affect people throughout our world. Recently, Congress has set out

on an ambitious path to increase funding for NIH, and we have

seen the budget double in the last number of years. We have not

seen NIH reauthorized in 12 years, since 1993, and recent hearings

have pointed to a need for interagency cooperation and coordination to help maximize the resources of the Institutes.

We must give the Director the ability to manage the NIH portfolio to focus on research that yields results, cures to diseases that

are within reach. In the January 2004 edition of Health Affairs, Dr.

Zerhouni said: ‘‘We need to be able to plan across NIH. We need

some funds in common. If you have 27 fingers out there with no

palm, you don’t have a hand.’’

I look forward to this hearing, to hear Dr. Zerhouni’s impressions

of the hand that you have been dealt, and what we can do to give

you the upper hand as we go through the reauthorization process,

and as we try to enable NIH to find the cures to diseases which

affect so many people throughout the world.

Thank you, Mr. Chairman. I yield back.

Mr. DEAL. Oh, well, at least we don’t have a paradox today. Recognize Ms. DeGette.

Ms. DEGETTE. Thank you, Mr. Chairman, and I would like to add

my welcome to Dr. Zerhouni.

The last time we authorized the NIH was 12 years ago in the

House, and when you think about the status of medical research

12 years ago, you really realize why reauthorization of this important agency is well overdue. The nature of medical research and,

frankly, the integration of research that we are seeing among the

27 Institutes has grown dramatically in the last 12 years.

7

I agree with Mr. Waxman. The system is not broken, and that

is why it is such a pleasure to be reauthorizing the agency at this

juncture. But I think it is important that we discuss what the balance is between the 27 fingers and the palm of the agency, and we

really try to figure out how we can keep the autonomy and the important research that is happening among those 27 agencies, but

at the same time, use the Director’s Office to ensure that cross-fertilization happens in the important way that it can, because that

is the only way that we will really see medical research advance

in the 21st Century.

Thank you, Mr. Chairman.

Mr. DEAL. Thank the gentlelady. Anyone else on this side have

an opening statement? If not, anyone on the top row here? Yes. Mr.

Stupak.

Mr. STUPAK. Thank you, Mr. Chairman. Dr. Zerhouni, thanks for

coming here today. I look forward to your comments.

Since I have 1 minute, I am going to focus on one area of this

draft legislation that I find troubling. The draft strikes a section

of the Public Health Service Act that authorizes pediatric drug

studies at NIH. This Section, 409(i)(d), was added in 201 as part

of the Best Pharmaceuticals for Children Act. The BPCA reauthorized a law that gave drug companies patent extensions in exchange

for testing the drugs on children. The incentive doesn’t work if the

drug has no patent protection left, therefore Congress created a research fund within NIH to study drugs that are off patent.

It is one of only a few provisions in law that actually mandates

FDA and NIH to work together on drug safety. This draft would

strike that provision. The sad fact is that Congress has never funded this provision, but it does not mean it is not important. It is

more important than ever. Off-label use by children of drugs approved and labeled only for adults is rampant. The FDA has no

power to restrict off-label use, and the list of drugs that need to be

studied continues to grow. If the FDA cannot or will not enforce

drug companies to do these studies, then at the very least, we

should not eliminate a safeguard that gives parents some assurance that their children’s drugs will be tested for safety and efficacy.

I look forward to working with this committee on this issue, and

will be submitting additional questions to the record. Thank you,

Mr. Chairman.

Mr. DEAL. I thank the gentleman. I might tell him that due note

has been made of your concerns, and will be addressed in the next

draft.

Mr. Allen.

Mr. ALLEN. Thank you, Mr. Chairman. Welcome, Dr. Zerhouni.

I hope you enjoyed your brief visit to Maine, and I want to thank

you for your leadership at NIH.

I just wanted to mention several concerns about this draft. First,

the committee needs adequate time to consider this legislation, and

to obtain input from stakeholders. Second, a question. To what degree should the Director have the authority to add, remove, and

transfer Institute responsibilities without ensuring a transparent

public process? I do worry that the concentration of so much power

8

in the office of the Director could result, could, in ideological and

political considerations trumping good science.

Third, this draft legislation appears to create an arbitrary ceiling

of Federal investment in biomedical research. Establishing a ceiling would seem to directly contradict Congressional success in doubling the NIH research budget, and imposing a ceiling could also

hamper the agency’s ability to deal with new public health threats.

We just passed an appropriations bill with the smallest increase for

NIH in 36 years, so at least now, the budget is growing slower than

the costs of inflation and new research.

Finally, I believe that legislation to reauthorize the NIH should

address the violations of NIH scientists engaging in outside consulting agreements with pharmaceutical companies, and I want to

commend Chairman Barton and Ranking Member Dingell for their

leadership on this particular issue.

I look forward to hearing from you, and with that, Mr. Chairman, I yield back.

Mr. DEAL. I thank the gentleman. Ms. Solis.

Ms. SOLIS. Thank you, Mr. Chairman, and welcome, Dr. Elias

Zerhouni. I am very interested in hearing what your testimony will

reveal to us today.

But one of the concerns I have is, I happen to represent a very

diverse district in Southern California, where we are finding that

access to health care, as you know, is a crisis—it is in a crisis stage

for many of the constituents I represent. But more importantly, the

diverse communities, not only in Southern California, but across

the country, we increasingly see that there is a lack of research

being done in these different racial and ethnic minority communities. We are trying to combat chronic illnesses, asthma, diabetes,

obesity, and other related illnesses that affect, at a higher degree,

more minority populations. We would like to see, I believe, more

research done, not in a vacuum, not in just one office, but spread

out throughout NIH, so that there are different calibers of individuals and researchers that can provide new, innovative information,

so we can combat these illnesses, and hopefully, look at ways of

prevention, and making that service available in languages and

culturally competent, meaningful ways that will actually make a

difference for our populations.

There are no party lines when you talk about healthcare access

in communities of color that many of us represent in the House, so

I would hope that you would keep an open mind, and work with

us, the Members of the Congress, to see that we really achieve parity, in terms of eliminating disparities amongst our communities

that currently are faced with some severe challenges and a crisis

in healthcare.

So thank you very much.

Mr. DEAL. I thank the gentlelady. Anyone with opening statements? Yes, Ms. Baldwin.

Ms. BALDWIN. Thank you, Mr. Chairman, and thank you, Dr.

Zerhouni, for joining us again. I enjoyed our discussion when you

appeared before this committee’s Health Subcommittee back in

March, and look forward to it continuing today.

Biomedical and behavioral research that is conducted at or coordinated by the NIH is of utmost importance to all of America,

9

and particularly, in my district, which includes one of the Nation’s

leading research institutions. I applaud the chairman’s focus on

this important part of our government, and I hope that, given the

size and the importance of NIH, that we do take a thorough,

thoughtful, and measured approach to NIH reauthorization.

Now, I have some concerns surrounding NIH reauthorization,

and some of those concerns have been amplified with the circulation of the discussion draft last week. As I expressed at the subcommittee’s hearing in March, I have observed ongoing and recently heightened efforts to politicize science and the conduct of research, and I believe that we have to insist upon safeguards to prevent this, and certainly, the time tested peer review process must

be protected at all costs.

I just want to end by noting that, while it is a delight to have

you return to the committee, I do hope that we will have further

hearings on this important topic with some of the other stakeholders that are involved in NIH reauthorization, especially researchers, research institutions, and patient groups.

Thank you, and I yield back, Mr. Chairman.

Mr. DEAL. Thank the gentlelady. Any other opening statements?

[Additional statements submitted for the record follow:]

PREPARED STATEMENT OF HON. PAUL E. GILLMOR, A REPRESENTATIVE IN CONGRESS

FROM THE STATE OF OHIO

Thank you Mr. Chairman for holding this hearing and bringing before us a discussion draft aimed at reauthorizing the National Institutes of Health (NIH).

Very briefly, our last NIH revamp bill was enacted 12 years ago, and we must

continue to focus carefully on the current organizational, funding, and management

structure of the NIH in order to make significant headway in reauthorizing and improving its 27 medical research institutes and centers. We must ensure that the

NIH continues to meet our public health needs as well as embrace cutting-edge scientific opportunities.

I welcome Director Zerhouni, and again applaud Chairman Barton’s initiative. I

yield back the remainder of my time.

PREPARED STATEMENT OF HON. JOE BARTON, CHAIRMAN, COMMITTEE ON ENERGY

AND COMMERCE

Thank you, Dr. Zerhouni, for testifying once again before the Committee. And I

thank all of the organizations and Members who have expeditiously responded with

constructive feedback to improve the first discussion draft we distributed last week.

It’s time for us to do our job and have the Energy & Commerce Committee reauthorize the National Institutes of Health. This job is critically important and long

overdue. With great fanfare, we doubled the budget of NIH. Unfortunately, NIH did

not have the mechanisms in place to either account for the increases or strategically

apply them. It still doesn’t, and that must change.

To date, NIH continues to lack the capability to track dollars across institutes and

centers for particular types of research or by disease categories. Only authorizing

legislation can put in place the long overdue management tools that NIH needs to

provide rational accountability to an agency that needs efficiency as much as it

needs money.

I strongly believe that the NIH could be better organized to achieve its mission.

This sentiment is shared by many. Nearly two decades ago, the Institute of Medicine reported, when NIH was 10 units smaller and had a budget of $4.5 billion—

less than 15 percent of the size of the President’s FY06 budget request for NIH—

that there should be a presumption against the creation of new research institutes.

The alarm bells sounded and Congress ignored them. NIH has grown like topsyturvy and now there are 27 Institutes and Centers.

Let me be clear. I don’t have a problem with the research programs at the institutes and centers. I’m not looking to cut the budget of NIH, nor weaken the fundamental role that the individual institute and center directors play in fulfilling their

10

research agendas. But someone needs to be in charge of strategic planning for the

agency. No one in his right mind would ever design a $28.5 billion agency that is

fragmented 27 ways with a director with only limited control.

Dr. Zerhouni is certainly to be commended for the job he is doing with the power

he can currently exercise. In three years time, he has put in place new management

mechanisms to advance cross-cutting, interdisciplinary science. Congress can help

Dr. Zerhouni to move forward with these initiatives by moving forward a reauthorization bill.

It’s time for this Committee to recognize that it has serious responsibilities with

respect to this agency. We can’t simply require NIH to conduct more research by

spending more money; we must demand that NIH achieves more with taxpayer

funds. The status quo is simply unacceptable. On that note, I would like to personally thank Mr. Dingell and Mr. Brown for their help in moving forward this legislation. As I said months ago, the NIH enjoys bipartisan support, and the bill to reauthorize it should be bipartisan as well.

The bill that is the subject of this hearing today was drafted with two key policy

principles in mind: no institute or center at NIH would be favored, nor would the

bill pick and choose disease winners and losers. I ask my colleagues to keep these

important principles in mind as we move forward to improve the bill.

Instead, the bill provides a framework for NIH scientists, not politicians, to identify areas of emerging scientific opportunity and take action to improve public

health outcomes. The discussion draft creates a new, comprehensive electronic reporting system that will, for the first time, catalogue all research activities of the

NIH in a standardized format. Instead of thousands of pages of reports from each

of the research institutes and centers, the NIH Director will compile biennially a

report that comprehensively lays out the strategic plans and research activities of

the agency.

The bill will let the NIH Director direct by establishing a formal strategic planning process for the entire research portfolio of the agency that transcends the research planning activities of individual Institutes and Centers.

And finally, the legislation streamlines how we fund research activities at the

NIH. Science has changed, and so too must the agency that funds it.

By reauthorizing the NIH, we are once again recognizing the critical importance

of the biomedical research enterprise that will lead to the next generation of medical

breakthroughs and therapies. I look forward to working with Members of this Committee to see that this long overdue bill moves not only through the Committee, but

is enacted into law.

Mr. DEAL. If not, we will then proceed with Dr. Zerhouni. We

are, once again, pleased to have you here, and look forward to your

testimony.

STATEMENT OF ELIAS A. ZERHOUNI, DIRECTOR, NATIONAL

INSTITUTES OF HEALTH

Mr. ZERHOUNI. I am very honored to be here, Mr. Chairman, and

members of the committee. I think this is probably a defining moment for NIH. There are transitions that are occurring in science

as we speak. There are transitions in the way science is conducted,

and this topic requires the attention that you have exerted over the

past 2 years with 11 hearings. This is my seventh appearance. I

have submitted a written statement, and to leave ample time for

both comments and questions, what I would like to do is summarize my comments through a slide presentation, if I may.

Clearly, what we are trying to do here, all of us, is to find a better way for NIH, a way that in no way implies that NIH has not

been a highly performing organization. In every measure, whether

it be GPRA plans or progress in science, or breakthroughs, or impact on public, I think we can say that NIH has been a remarkably

successful organization over many, many, many years.

It is important to also remember that our basic authority comes

from the PHS Act, Section 301, which states that the Secretary

shall conduct in the service and ‘‘encourage, cooperate with, and

11

render assistance to other appropriate public authorities, scientific

institutions, and scientists in the conduct of, and promote the coordination of, research, investigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of physical and mental diseases and impairment of man.’’

And I think what the committee is doing is to reinforce this fundamental authority. We are the primary Federal agency authorized

by this committee to conduct and support medical research, and I

think the efforts that we are seeing have also been, in many ways,

summarized in this list, where, in fact, the basic authorities do

allow us to prioritize research at NIH through fundamentally an

organizational structure, Institutes, Centers, that are created for

special purposes related to perceived scientific opportunities or

public health priorities.

It mandates biomedical research, it provides grant-making authority. It mandates a system of peer review which is the envy of

the world. It is a world-renowned system that ensures that quality

science is funded on a competitive basis. It mandates training for

the workforce that we need to address the problems we are dealing

with. It also mandates dissemination of information, that the information we generate be made public, and be made available to the

public who funds that research, even subject to protections as well,

as a wide solicitation of the public advice.

And I think the draft that is being circulated reinforces these authorities, and maintains them, and I want to comment and say

that, to me, this is the most important set of reaffirmation of the

success of the agency by reaffirming its fundamental authorities. It

is clear, however, as the Institute of Medicine study, entitled ‘‘Enhancing the Vitality of the National Institutes of Health: Organizational Change to Meet New Challenges,’’ said that ‘‘while the NIH

is to be celebrated, success alone does not answer fully the question

of whether there is a better way to proceed.’’

Particularly, as one faces a future where the world of biomedical

science is being rapidly transformed in virtually all its dimensions.

I would like to take a second. There is a quote on the wall there

that says: ‘‘Where there is no vision, the people perish.’’ Proverbs

29:18. And I think this is what the IOM and your committee, and

our own community, have been indicating. If, indeed, there is a

transformation, and there are different priorities, how do we set

those priorities? What is the organizational challenge we need to

tackle as we go into an era of biomedical and behavioral and social

science research that is characterized by much more complex problems, problems that affect an entire population at times, problems

that affect an aging population, conditions that have become more

chronic, more long-term, than the conditions we dealt with 30, 40

years ago. You can survive cancer today. You can live with cancer

as a chronic disease. You can live with AIDS as a chronic disease.

You can live and survive heart disease for many, many years. The

landscape has changed, and I think we need to adapt as well.

Now, at the March 17 hearing, this chart was highlighted by

Chairman Barton as illustrating both the opportunity and the challenge that we have. Clearly, as any successful organization, we

have grown in size, we have grown in complexity. To the same exVerDate 11-MAY-2000 07:18 Dec 05, 2005 Jkt 000000 PO 00000 Frm 00015 Fmt 6633 Sfmt 6602 22987.TXT HCOM1 PsN: HCOM1
12

tent, the complexity and scale and scope of the public health problems we have to deal with have also grown. And as I said, the organization of NIH is primarily an organization driven by structure.

So how did we evolve the structure; 27 Institutes and Centers represent the operating arms of NIH, what I refer to as the fingers,

if you will. The palm, on the other hand, is represented by some

of the coordinated offices, which you see at the top left hand corner,

the offices that have been created for the purpose of better coordination, the Office of Research on Women’s Health, the Office of

AIDS Research, the Office of Behavioral Social Sciences Research.

So as you can see, as time has gone by, more structures have been

created. But at the same time, we have attempted to create what

Representative Ferguson mentioned as the palm. And I think the

balance between the palm and the fingers is really our challenge.

A strong palm with no good fingers is not a good hand. Strong fingers without a palm is not a good hand either.

So I think going forward and analyzing the proposed circulation

draft, these are some of the observations that we can make. I think

if you really look not in the structural way at NIH, but in the functional way, what you find is you have Institutes that are specifically directed to research and science that addresses either a disease or a disease process, or an organ, the Heart and Lung Institute, or a particular disease, like diabetes, or a life stage, childhood, or the aging population. These are what I call vertically oriented institutes that integrate all of the components of research

needed to address a particular problem, as identified through our

public health priority stance.

These are the 15 Institutes that support research specific to either a disease, an organ, or a life stage. Now, any complex organization cannot work when there is only a vertical orientation of each

structure. In fact, other Institutes have, for function, research, and

science that is just as valuable as the what we call mission specific

Institutes, but it supports what applies to all diseases, all organs,

all life stages. For example, every discovery at the National Human

Genome Research Institute applies to the entire aspect, the entire

spectrum of challenges NIH has. We were talking about cross-cutting issues. These Institutes really perform the function of crosscutting science, and cross-cutting issues like minority health, for

example. Basic science, the National Institute of General Medical

Sciences, performs science that applies to the entire set of diseases,

ages, conditions, organs of the human body.

At the same time, as I mentioned, in the top left corner, there

are five program coordination offices that are specific to particular

areas of the portfolio. When you think about organizations like

this, you also have to realize that as the landscape has changed,

what also happened is that with chronic diseases, patients are not

affected by one disease at a time, or one organ at a time. They are

often affected by multiple failures involving multiple organs. Diabetic patients may have a vascular problem, a neurological problem, as well as a problem of metabolism. So, it is important to realize that barriers and silos become, in themselves, both instruments

of effectiveness, but also, instruments by which you lose effectiveness, if you are not able to create that glue.

13

So I think the concept, the committee’s conceptual framework, is

a good one. It is truly going from structure, and enhancing that by

a functional analysis of what NIH does. However, the one piece

that I believe is important is to create the ability for the NIH, on

a prospective basis, to analyze its portfolio, to have a real radar as

to what is it that is being done within the agency, what is it that

needs to be done, that no single institute can do, and what kind

of coordination can you accomplish, and how do you accomplish it?

And how does it impact budgets? Do you want to direct all research

from such an office? No. Centralization is counterproductive in

science, excessive centralization, too much top down research. Do

you want to have no coordination? Well, the answer is no. Somehow, somewhere, I think the committee is proposing a structure

that will accomplish this goal, which is very parallel to what the

IOM recommendations have been, and very parallel to what my

own actions have been on the ground, when we try to develop

trans-NIH programs, such as the Roadmap for Medical Research,

or the Blueprint for Neuroscience, or the Trans-NIH Obesity Plan.

This OD division would be essentially supporting the glue mechanisms, the coordination—not dictate, but enhance and synergize research. It will include the five specific program coordination offices,

which will continue their roles, because they were created to fulfill

a gap, which was coordination, and I think they need to continue

to do that job.

So in summary, I think you can see that going from a structural

organization to a more functional organization does make the case

that an authorization structure that would encourage, rather than

discourage, integration, that it would encourage synergy, while not

losing the autonomy and the ability for the most significant part

of the activities of the Institutes and Centers, to be focused on their

mission. I think we do see, in my personal view, a great wisdom

in what the committee is proposing.

I would like to mention, fundamentally, that NIH and its directors have tried to facilitate cross-cutting collaborations over time.

I think it is true that science has changed over the past 12 years,

and we have tried to adapt to it. We have adapted to it by an ad

hoc process, which I don’t think is codified or formalized, and we

have shown that it can work, so when we say let us go forward,

and make a change, I think I resonate with those who say make

sure you don’t break the agency. Make sure that what you are proposing works. And I think we have shown that it can work. The

Roadmap for Medical Research is one example where all the Institutes have come together, and pooled funds, admittedly, at a time

of generous budgets, and have put those funds together to work

over a 5-year period, and continue to see this as a valuable initiative. The Strategic Plan for Obesity, or the NIH Neuroscience Blueprint, I think this will accelerate the progress, and make sure that

there is, at least, an exploration of a better way.

When you look at the role of this division, I think it will provide

consistent analysis across Institutes. It will provide streamlined reporting to Congress. It will provide prospective analysis of emerging areas, either scientific opportunities, like nanotechnology, or

proteomics, rising public health challenges, like obesity or any

other knowledge gaps can be addressed objectively, on the basis of

14

a transparent and publicly available analysis. I think in conjunction, it should not be done separately from the ICs, in conjunction

with the ICs, we should identify the areas that require strategic coordination, where no single Institute can really accomplish the goal

that we would like to achieve. And it should launch initiatives that

are beyond the purview or resources of any one Institute or Center.

High risk, high reward research is difficult to launch when you

don’t have a common pool of funds that allow you to share the risk.

This is, I think, what will serve NIH as a whole.

So we need to make sure that whatever we do does not supplant

what has worked, or dictate IC-specific plans. I don’t think it is the

role of this division to go to the Institute for Cancer and say, ‘‘You

shall do so.’’ I think it is more important that we stimulate explorations for a part of the portfolio of NIH, to make sure that no

stone goes unturned, that if there are opportunities to treat, to

make progress, that those are prospectively, in a formalized process, evaluated.

This institutionalized mechanism for allocating a percentage of

the total NIH budget for greater synergy is, I think, the core, to

me, of the reauthorization concept that I see, which I think would

be very valuable. Essentially, it will be a common fund for common

needs, with a process that would be, obviously, transparent, that

will call for consultation, that will have the right checks and balances for oversight, but at the end of the day, in an era where

science has become interdisciplinary, collaborative, and converging

in many cases. Most of the research we do at one Institute applies

to another. The first treatments for HIV/AIDS actually came from

research that was done at the National Cancer Institute. There is

no firm separation of good science. There is only good science and

good public health.

So in summary, I think that it is clear that the bill, as drafted,

does provide, in my view, a higher level of coordination. And I,

again, should say that it should not bleed into centralization. I

think it should provide input from NIH Institutes and Centers, outside scientists, and the public. It should assess, like I said, a radar

of the public health landscape, look at the scientific landscape on

a regular and organized and disciplined basis, and manage the

NIH portfolio for maximum return on the investment, if you will.

But it will also, in my view, allow something that is always difficult to accomplish in a complex organization, nimbleness, the ability to be dynamic and responsive to quickly emerging opportunities,

not wait for the 3 year or 4 year cycle, to be able to address a question, but to be there, on time, with the right amount of money, the

right amount of resources, when we need it.

So in summary, I think I am indicating to you a willingness to

work with the committee. I think I hear the need for us from the

standpoint of policy and national interest, to look carefully at the

reauthorization of NIH. We will work with the committee and the

staff, in any capacity, to provide the technical assistance that you

may wish to have, but, in my view, I think the committee, after 2

years of work, is proposing something that has a functional component to it that does make sense.

[The prepared statement of Elias A. Zerhouni follows:]

15

PREPARED STATEMENT OF ELIAS A. ZERHOUNI, DIRECTOR, NATIONAL INSTITUTES OF

HEALTH, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Mr. Chairman and Members of the Committee, today is my seventh appearance

before the Energy and Commerce Committee or one of its Subcommittees. I have

testified about a variety of topics, including research priorities, the organization of

Institutes and Centers, scientific peer review, the shift of the Nation’s health care

burden from acute to chronic diseases, and the need to revolutionize the methods

and systems we use to conduct and manage biomedical research.

Each time I testified, I noted the remarkable achievements made in the course

of biomedical research, ranging from mapping the human genome to reducing mortality from cancer, AIDS, and heart disease to the rapid progress in the development

of vaccines. But I tempered the stories of success by describing the daunting journey

that lies ahead of the scientific community as we grapple with the remaining obstacles impeding progress towards the prevention, diagnosis, or treatment of the many

causes of human suffering. Much more needs to be learned about human biology

and behavior. Emerging and reemerging infectious diseases continue to threaten the

world. Chronic diseases are growing in terms of their impact on quality of life and

the economic future of America and other countries. The threat of bioterrorism continues to loom. Health disparities remain a widespread problem.

As the Institute of Medicine (IOM) has observed, ‘‘While NIH’s success is to be

celebrated, success alone does not answer fully the question of whether there is a

better way to proceed, particularly as one faces a future where the world of biomedical science is being rapidly transformed in virtually all its dimensions.’’

This quest for the ‘‘better way,’’ as the IOM describes it, is also at the core of insuring continued scientific progress in an era when the scale and complexity of the

problems we are facing require constant innovation, increased interdisciplinary efforts, and a balanced portfolio of basic, translational, and clinical research investments across all NIH Institutes and Centers. Based on my own interactions with

the Members of this Committee, I know you too strive to find the ‘‘better way.’’

The IOM had several key recommendations worth recalling in the context of today’s hearing. It recommended that the ‘‘Director of NIH should be formally charged

by Congress to lead a trans-NIH planning process to identify major crosscutting

issues and their associated research and training opportunities and to generate a

small number of multi-year, but time limited, research programs.’’ The IOM proposed that NIH present the justification for trans-NIH budgeting to Congress and

that the funding for such research should be held in an escrow account. It recommended that such research be included in the President’s budget request to Congress for NIH.

The IOM suggested that NIH have a formal process for reorganizing offices and

programs.

The IOM also recommended standardizing data and information systems at NIH

to enhance management, accountability, and transparency.

The IOM report was followed by three years of analysis by the Committee and

its staff. I think it is noteworthy that the IOM and the Committee reached similar

conclusions about NIH. Many of these conclusions are manifested in the reauthorization concepts offered by the Chairman and Ranking Member.

In thinking about NIH reauthorization, I want to begin with the core research authorities embodied in Title III of the Public Health Service Act, which authorize the

Public Health Service to ‘‘encourage, cooperate with, and render assistance to other

appropriate public authorities, scientific institutions, and scientists in the conduct

of, and promote the coordination of, research, investigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and

prevention of physical and mental diseases and impairments . . .’’

I believe this core authority is the fundamental reason why NIH has been so successful in its mission. I applaud the Chairman and Members of the Committee for

maintaining these and other vital authorities, such as peer review, the pursuit of

scientific opportunity through investigator-initiated grants, human subjects protections, and the requirement to disseminate research findings to the public. In its own

search for the better way, I think the Committee is correctly focused on organizational efficiency and effectiveness, which is the principal challenge for an increasingly large and complex organization.

I agree with the Chairman that we should first and foremost carefully reconsider

how the organizations of NIH can collectively and effectively support the core missions of the agencies. The challenge is to accomplish this goal through enhanced coordination and partnerships across the NIH Institutes and Centers while avoiding

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ious Institutes and Centers while avoiding the silo effects that can reduce the effectiveness of the whole Agency is the central question. How can the whole be greater

than the sum of the parts? As I said in the past, twenty-seven fingers without a

palm is not a strong hand. Likewise a strong palm without strong fingers is also

ineffective.

I agree with the Chairman that NIH needs an organization, such as the proposed

division of program coordination, planning and strategic initiatives, that will serve

as a coordinating office for evaluating on a regular basis the progress of science in

the context of public health priorities. It will be responsible for analyzing and reporting with consistent methods the portfolios of NIH research that cross the boundaries of multiple Institutes and for identifying trans-NIH research needs that no

single Institute can address but that all of NIH needs to support. This structure

should be able to conduct appropriate strategic planning for emerging areas of scientific opportunities or challenges and to develop important data and intelligence

to support a more comprehensive and informed priority setting process. As you

know, the Administration has proposed such an office. I support the concept that

this office be able, through a codified process that includes participation from all of

the Institutes and the scientific community at large, to allocate resources to initiatives that serve the common good, subject to review by an advisory committee. However, I do not think this office should actually conduct the research resulting from

any initiatives it identifies. I believe that this research is more appropriately conducted by the existing Institutes and Centers.

The Chairman also proposes to clearly define the roles of NIH Institutes and Centers. I agree that each Institute and Center should have a defined purpose in support of the overall mission of NIH. The Chairman has proposed categorizing Institutes and Centers into either mission-specific or science-enabling responsibilities.

This has resulted in the perception that one category is more significant than another. I understand that this is not the intent. All of the Institutes and Centers support vital research. Some engage in broader areas of science that are useful to all

of NIH’s organizations while others are involved in more specific areas of research,

focusing, for example, on cancer, heart disease, or infectious diseases. Their research

is of equal value to the scientific community.

I will work with the Committee to clarify the roles of each of NIH’s Institutes and

Centers. I agree with his goal of clearly defining how each of these organizations

serves the overall mission of NIH and ensuring that the Agency does not consist

of 27 silos that do not work in coordination.

In further pursuit of the ‘‘better way,’’ the Chairman has proposed consistent coding and reporting of research and a more transparent, efficient mechanism for reporting the results of NIH research to Congress and the general public. I agree that

these steps are necessary, and I will work with the Committee to accomplish these

goals in a way that will enhance the public’s understanding of how NIH works,

while not unduly inhibiting the Agency’s ability to conduct and translate research

quickly.

In conclusion, I pledge my cooperation to work with the Committee as it considers

reauthorizing the NIH provisions of the public health Act. I look forward to answering any questions that you might have.

Mr. DEAL. Thank you. I will begin with the questions.

As you know, we are considering in this proposal to divide the

various Institutes and Centers into two big categories, one that is

mission specific Institutes, and two, the science enabling Institutes

and Centers. What do you think about this approach to that two

major divisions?

Mr. ZERHOUNI. I think functionally, you can see that the mission

is actually different for the two groups. It is really important to

have the ability to coordinate planning between these. As I said,

for example, you may have conditions and diseases that affect multiple organs. Diabetes affects the cardiovascular system, affects the

brain. So you want more coordination around diseases, for example,

that go across multiple Institutes that are focused on diseases.

At the same time, in the cross cutting Institutes, that are just

as important, you may see an emerging discipline. You may see

something that—a methodology, or you may actually want to, for

example, develop computational biologists. Well, that cannot be

17

done by any one of them in isolation. So there is, I think, merit

to—from the planning standpoint, to have these Institutes make

sure that they get coordinated in a way that is strategically directed.

Mr. DEAL. I am sure most of us have heard from groups that feel

like they are not adequately represented within the silos that currently exist, and one of the complaints is that they get shuffled

from one to the other, that this is not that institute’s responsibility,

it is somebody else’s.

One of the ways that we have anticipated trying to deal with

that is through the reporting system that is in the draft legislation.

Do you believe that this reporting system is a good way to let the

public know what is or is not being done and by whom, and is this

an important ingredient in setting priorities for you within the

NIH itself?

Mr. ZERHOUNI. First of all, I would like to commend the committee, for looking at this issue of reporting. It is a consuming activity that consumes a lot of resources and staff time, for a benefit

that is not necessarily there. So I think streamlining reporting

would be of great value to us, and strategically reporting, in an appropriate way, would be important. But think about it. If you had

a division like this, that had consistent ways of recording data and

information, that across all activities, the NIH had a way, a consistent way, of reporting it dynamically, if you had an issue, you

wouldn’t have to create a report, or a need for a report. What you

would do, you would say this division should be charged to look at,

for example, in the case of autism, we developed an autism plan,

called an autism matrix, and the case of Parkinson’s disease. And

the question should be what is in the portfolio, and what is science

telling us, or public health telling us, that we are not doing. That

sort of dynamic reporting is, I think, the future, but you can’t do

it unless you have the tool to do it. And I think, with the tools, we

could streamline it.

However, I think mandated reports of a very large size, basically,

in my view, would be counterproductive. We need to be more nimble. We need to be more accessible. I think someone said accessible

public information. That, I think, will solve the problem eventually.

So I am in favor of streamlining reporting.

Mr. DEAL. Thank you. Mr. Brown.

Mr. BROWN. Thank you, Mr. Chairman. Dr. Zerhouni, I just have

a series of short questions, and I hope that, if possible, you can give

pretty quick answers to them.

One of the questions before the committee is whether we include

specific authorization levels in a bill reauthorizing NIH. Do you

support the committee legislating a hard ceiling, or—a hard ceiling

on NIH funding?

Mr. ZERHOUNI. Well, you are creating a real conflict in my mind

here. As the Director of an Agency, there is no ceiling that is good

enough, but I do understand the necessity for the authorizing committees to look at that issue, and clearly, I think it—like we said,

it really depends on the total structure of the authorization bill,

and the specific amounts, and so on, over what time. I think the

details need to be worked out, and would be happy to talk about

the consequences. It needs to be done carefully, if it is to be done.

18

Mr. BROWN. Well, if we have ceilings or caps, let me push it a

little further. If we have ceilings or caps, what is an appropriate

percentage increase? What is an appropriate number, if there are

those caps or ceilings?

Mr. ZERHOUNI. I think you need to really look at the planning

process, and you need to look at the opportunity well. I mean, you

can’t tell what emergencies will occur, what opportunity will come.

So it is very, very important to leave yourself a significant amount

of flexibility.

Mr. BROWN. I am not going to get a specific—answers that I

want here, am I?

Mr. ZERHOUNI. I am willing to work with the staff and the committee. I think it is something that needs to be looked at in greater

detail.

Mr. BROWN. The draft contains several different authorities for

the Director to transfer funds within the National Institutes of

Health. One of these follows the Institute of Medicine’s recommendation that each Institute and Center set aside a percentage

of its budget into an escrow type account to be applied toward

trans-NIH initiatives, as we discussed, a sort of common fund.

What is an appropriate percentage that we should set aside, if we

do it in the authorizing language for trans-NIH authority?

Mr. ZERHOUNI. Well, clearly, I think, it wouldn’t be meaningful

if it is not a meaningful percentage. I think—and I think the IOM

recommended beginning with 5 percent of the overall NIH budget,

and I think that this is a good way of making sure that the NIH

Institutes come together on a regular basis, because this is not

transferred away from the Institutes. I think it should stay within

the Institutes, but allocated dynamically over a period of time, and

the initiatives to which it is allocated should not be permanent initiatives. They should be time limited. If you do that, I think, obviously, you need to have a significant portion, 5 percent is, in my

view, a good recommendation as a minimum.

Mr. BROWN. As a minimum.

Mr. ZERHOUNI. For a common fund.

Mr. BROWN. Yes.

Mr. ZERHOUNI. Now, there is a difference between——

Mr. BROWN. You are saying a minimum——

Mr. ZERHOUNI. [continuing] a minimum——

Mr. BROWN. [continuing] or the optimal number, 5 percent.

Mr. ZERHOUNI. I am reading you the——

Mr. BROWN. What do you think?

Mr. ZERHOUNI. I think 5 percent should be a minimum.

Mr. BROWN. Okay, a minimum. Okay. And you want to set it up

so that it is not an entitlement, so that it doesn’t ultimately lead

to another Institute, in effect.

Mr. ZERHOUNI. That is right. I think the idea of creating another

structure that has funds, and allocates that to—over an infinite period of time is not the concept. The concept here is to create an organization that will identify what areas to incubate better, what

emerging areas need to be supported, what emerging areas need to

be funded. But it shouldn’t be forever. It should be time limited,

and we can discuss how to do that, technically, but I don’t believe

that those initiatives should live there forever.

19

Mr. BROWN. And what other kind of transfer authority that the

Director, that allows the Director to transfer funds from one Institute or Center to another Institute or Center. My understanding of

current law is that you have the authority to transfer 1 percent of

any of the Institutes’ or Centers’ budget in this way. In that 1 percent, that—my understanding, that is what the appropriators have

done, have allowed. I am not sure that we have addressed that.

Have you made use of that 1 percent transfer as Director?

Mr. ZERHOUNI. Okay, historically, if you look at the use of the

transfer authority, because it is an authority that comes post facto,

it is not planned ahead of time, and if you know the reality of the

budget process, you have to plan at least 2 years ahead of time. We

are currently dealing with the 2007 budget, while the 12006 is not

done. So what you really need, transfer authority is only used in

cases where your planning missed something. Something happened

where you need to quickly react to a—something on the ground

that is happening in real time, so you transfer small amounts. So

historically, the transfer authority has never been used for a prospective, strategic purpose. It is usually reactive and post facto. So

the transfer authority doesn’t have to be a large authority. The

common fund concept, however, needs to be real and significant.

Mr. BROWN. Last question, real quick, Mr. Chairman. On the

transfer authority, not the common fund, but the transfer from one

Institute to the other. Is the—should the 1 percent number be in

the authorizing language? Should it be 2, should it be a half? I understand that you haven’t used it—you have used it very infrequently, if at all. What should we do there? Give us a specific number.

Mr. ZERHOUNI. There is no doubt in my mind that it should be

in the authorizing language, because not being in the authorizing

language makes it unsure.

Mr. BROWN. What should be in the authorizing language, 1 percent, 2 percent, .5 percent, what?

Mr. ZERHOUNI. Again, I will have to think through what the topics are, but 1 to 3 is usually what people recommend, the AAMC

says up to 3, the IOM says up to 3. One to me—it depends on what

else you have. If you have a common fund that is in law, in authorization, where everybody knows that they have to come to the

table, and plan jointly, then the transfer authority can be smaller.

If you don’t, then you have to rely on the transfer authority, like

we did for the Roadmap, for example. The first year of the Roadmap, I used the transfer authority.

Mr. DEAL. Mr. Bilirakis.

Mr. BILIRAKIS. Thank you, Mr. Chairman. Doctor, you have spoken, and I would say pretty fondly, of the committee draft. Obviously, in your remarks, you didn’t go into the dollars of it. Mr.

Brown did, and I would sort of like to maybe hitchhike on his questioning.

In my opening statement, I was concerned that we not cause any

harm, basically, the old doctor’s education adage, ‘‘Do no harm.’’ In

that connection, thinking in terms of multi-year commitments in

research portfolios, thinking in terms of longer range planning,

which is, I guess, basically the same thing. Thinking in terms of—

or politics. Politics sometimes in NIH would be maybe even heavier

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than politics in Capitol Hill. Ultimately, it is the real world is, I

guess, is what I am talking about, the ability to shift funds. Talk

about that, in general.

Do you feel that the areas that you have not mentioned, such as

the four specific authorizations or appropriations, the competition

which is envisioned there, the transfer authority, the increased

transfer authority that would be given to your office. I think, even

though the legislation is blank, it leaves it open in terms of what

that percentage would be. It certainly envisions considerably higher than what your office now holds.

So in terms, again, of the things that concern the—tell us a little—take the rest of my time, and tell us a little about that.

Mr. ZERHOUNI. I think it is a very good area to focus on. From

my standpoint, what is really important here is to establish the

proper checks and balances, just like our system of government

works on checks and balances. There is always the possibility of

misdirecting decisions at the executive level, if you don’t have the

proper checks and balances. And I think the same is true, that you

could also have such an entanglement, and such a limitation on

what the executive can do that you are not getting an efficient organization. So the answer to that, I think, is what I believe in very

strongly. No. 1, complete preservation of the peer review process.

No. 2, relying on the input from the Institutes and Centers who are

closest to the action, understand the research, and have a process

that is formalized, where in fact, that consultation occurs. And

third, an outside oversight mechanism such as the Advisory Council of the Director, which is, in law, the mechanism by which all

Institutes, really, are overseen, with public members and scientific

members.

I don’t think it is as big a problem as I think some people are

afraid of, but I think it will depend on the details of how you establish the proper checks and balances, so that there isn’t excessive

authority being exercised on a discretionary basis without reporting back to Congress, and to the appropriate members.

Mr. BILIRAKIS. Well, but excessive authority, sir, and checks and

balances and whatnot, I mean, that is pretty darn subjective. It is

in the eyes of the beholder, I guess.

Mr. ZERHOUNI. Right.

Mr. BILIRAKIS. And so here, we put ourselves in the shoes of

these research facilities out there, and from the standpoint, again,

of the multiyear planning, and whatnot. There still would be, in

the hands of—basically, right now, of course, they are in the hands

of the Appropriations Committee’s up here.

Mr. ZERHOUNI. Right.

Mr. BILIRAKIS. They would be in the hands of the Director to a

very large degree.

Mr. ZERHOUNI. I think they would be balanced, because no

project that the Director can come up with will not—will be accepted without peer review. So all of those will go through that two

level of peer review process. Second, if you predicate the ability of

having an allocation done for a particular purpose, on the need for

a consultation with the Institutes, so that the scan that I am talking about is done, and remember that we are only talking about

trans-NIH areas of concerns, where the palm has to be stronger

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than it is today. I think it is doable. I don’t think—it is an achievable goal. Complex organizations do that all of the time. As long

as you have a proper oversight structure and the corporate board

structures to have enough input.

Mr. BILIRAKIS. You know, over the years, when I chaired the subcommittee, I guess the most terrible times that I had was when I

had people coming in to me in wheelchairs or whatnot, and they

wanted increases in research funding for that particular, specific

disease, and having to tell them that we have a policy here of not

basically telling NIH how they should spend that money. So I

guess you are making this—if this were to go forward, it probably

makes it easier on us, in the sense we would pass the buck on to,

I guess, to you, if you—is that correct?

Mr. ZERHOUNI. Well, I hope it is not the intent here, because I

would definitely see that as not a good evolution. I think, in fact,

the reason our American science is as good as it is, and NIH

science is as good as it is, is because of the wisdom of Congress in

avoiding specific earmarks independent of the peer review process,

independent of that check and balance system that is really the

envy of the world. So I would prefer to preserve that, rather than

have more coordination, to be honest with you.

Mr. BILIRAKIS. Well, thank you, sir. Thank you, Mr. Chairman.

Mr. DEAL. Thank you. I know that you cannot see the timer. The

only thing you can see is probably when the red light goes off at

Dr. Zerhouni’s table there. And we have a timer up here. The

Science Committee is just not as advanced as we are in our committee, but if you would try to watch that timer there, so we can

get everybody with questions. Mr. Waxman.

Mr. WAXMAN. Thank you, Mr. Chairman, Dr. Zerhouni, I want

to ask you about advisory committees at NIH. The National Research Council of the National Academy of Sciences recently recommended that appointments be made on the basis of scientific

and technical knowledge and credentials, and professional and personal integrity. Do you agree with that statement?

Mr. ZERHOUNI. Yes.

Mr. WAXMAN. The National Research Council also stated that it

is inappropriate to ask potential candidates for advisory committees about non-relevant information, such as voting record, political

party affiliation, or position on particular policies. Do you agree

with that view as well?

Mr. ZERHOUNI. Yes, I agree.

Mr. WAXMAN. In recent years, there have been serious allegations made that advisory committee appointments were dictated by

politics, and not science. In one well publicized case, an advisor to

a panel on drug abuse was asked whether he had voted for President Bush, and whether he supported abortion rights. In another

case involving the Fogarty Center on International Health, numerous proposed experts were rejected by the Department for apparently political reasons, and those rejected included a Nobel Prize

winner. Would you support clear language adopting the National

Research Council’s standards as guiding advisory committee appointments at NIH, and essentially saying the NIH Director would

make appointments without political interference by the Department, these appointments should be based on scientific merit, not

22

political litmus tests, and Congress should remove any temptation

to meddle with this process?

Mr. ZERHOUNI. Well, when I became Director I looked into them.

The NIDA case, for example, that was not a department selection

with NIH. You are talking about a Nobel Prize Committee member.

I understand that same person is now an advisor to the Office of

Science and Technology Policy. I have heard a report from one

member, who had been asked questions like this. So——

Mr. WAXMAN. Whatever happened in the past—in the future, do

you think it would be a good idea to write that into the language?

Mr. ZERHOUNI. Let me just say this, Congressman, that to my

knowledge, since I was aware of that one case, and I intervened no

one on any NIH council, peer review or advisory, is unqualified to

be on that council. So I want to make sure you know, my commitment is to, in fact, achieve that. And during my tenure, there has

not been——

Mr. WAXMAN. Dr. Zerhouni, I am not really being critical of you.

I am just asking for questions on this legislation. Do you think we

ought to write that in?

Mr. ZERHOUNI. By and large I think NIH is—should be apolitical.

I think it is apolitical, I think disease knows no politics. I think we

should really advise and inform, and do the research that serves

the entire country, and do it in the most objective way possible.

Mr. WAXMAN. You have been a strong advocate for NIH’s system

of peer review of grants, and its independence from political pressures. Do you believe the NIH Director should be able to defund

a grant that has passed peer review by an Institute?

Mr. ZERHOUNI. I think there would have to be really, a very, very

scientifically justified reason to defund it. We do have cases where

there are issues of integrity of the science, misconduct, where we

have to defund. So the NIH Director needs the authority to defund,

but not on the basis of a political decision.

Mr. WAXMAN. Well, the reason I ask is that the idea has been

floated to make the NIH Director responsible for eliminating unnecessary, duplicative research, and for ensuring balance in research. I understand the need to constantly——

Mr. ZERHOUNI. Well——

Mr. WAXMAN. [continuing] review NIH’s research portfolio, to

make sure it is responding to the challenges facing the American

people, but I am concerned about giving any Director, a political

appointee, you know, broad authority to second guess the scientific

experts to rate the grants in their fields. What should be the NIH

Director’s role in assessing the portfolio——

Mr. ZERHOUNI. I think priorities, in my view, should be allocated

and priorities means resource allocation, at the end. I think——

Mr. WAXMAN. But not micromanaging.

Mr. ZERHOUNI. Not micromanagement. You should really do it on

a prospective basis. For example, we allocated resources, greater

resources, to the obesity issue, that you know well, prospectively.

Once it goes to that level, I think the Director should trust the peer

review process, and not second guess a two level process. The peer

review process, two levels of independent review is the cornerstone

of NIH, and why it has been successful. So prospectively, doing priority setting, absolutely. Changing the relative weights, because

23

science changes, and public health priorities, absolutely. Retrospectively, I don’t think it is a good idea.

Mr. WAXMAN. Thank you. Thank you, Mr. Chairman.

Mr. DEAL. Chairman Barton, do you have questions?

Chairman BARTON. Mr. Chairman, I am going to defer at this

point in time, to kind of get a feel for the hearing, but—the Energy

Conference is in recess for 30 minutes, so before I go back downstairs, I would like to be called on. But I want to study up a little

bit right now.

I am glad to know where all my energy conferees are, though.

They are all up here at the NIH hearing. But I am going to defer

at this point in time.

Mr. DEAL. All right. Ms. Wilson.

Ms. WILSON. Thank you, Mr. Chairman, and thank you, Doctor,

for being here to testify.

I had a couple of questions. I had a particular interest in this

issue of managing research portfolios, which I think is very different than a lot of the other things that we manage in government. And I am interested not in what are the best opportunities

for research and science, but how do you determine what are the

best opportunities? What tools do you have as a Director, or within

and across your Institutes, for determining what the best opportunities are?

Mr. ZERHOUNI. Of how it is done. So fundamentally, about 60, 65

percent of the budget is allocated to what we call scientifically-initiated proposals, so it is investigator-initiated proposals, a scientist

out there has a great idea. They submit the idea to the peer review

process, which is the first step at the top, is the NIH grant proposal. It then goes to a scientific review panel. And only 25 percent

of these get ranked to be funded, and it goes through the program

officer. Now, the program officer in each Institute follows a particular strategic plan, that has been usually developed over a period of years by the Institute, to look at program importance and

program relevance. And that officer will determine whether or not

the grant fits with the program relevance of that Institute. And

then, it goes to the second level of review, which is the Institute

National Advisory Council, and that Institute has, in law, in statute, the authority to fund this research or not fund it, and sometimes, they will change the priorities at that level. And this goes

to the Institute Director, reported back to Congress, obviously. This

is the issue of reporting that we cover.

So this is done at the level of the Institutes, and the ability of

the NIH in total to combine all these portfolios is limited. This is

why, I think, this reauthorization strategy will provide the ability

to look across Institutes and across portfolios. And Institutes have

done that on their own, and many Institutes have come together

to look at areas that are common. Usually, with a lead Institute

serving as the disease-specific need. So the process seems complex,

but there is no doubt that within each Institute, planning is done,

has always been done, in a very effective way, and the Program Directors, in conjunction with the Advisory Councils, will then determine what the portfolio will be for that Institute.

What you don’t have, as effectively as we—what I believe we

should have, is a look across all portfolios, with analytical tools

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that tell you how much are you spending in this area of research

versus that one. And duplication is not necessarily bad in research.

You need to confirm findings. You want to have that. But it is the

balance, is the issue of what is the right balance.

25

Ms. WILSON. I find that interesting, that it seems to be driven from the bottom

up, from the researchers. There may be some value to that. At the same time, you

as a Director need to be——

Mr. ZERHOUNI. Right.

Ms. WILSON. [continuing] looking at what are the biggest problems.

Mr. ZERHOUNI. Right.

Ms. WILSON. [continuing] that we need to identify research roadmaps, and gaps

in research in order to fill. And that is—is there anything that you currently have

that does that kind of an assessment of here are the biggest health problems,

whether it is the cure for diabetes, which is driving health costs, or aging problems?

Do you have any mechanisms to do that?

Mr. ZERHOUNI. Actually, my answer was incomplete. Sixty-five percent of the

budget is allocated to investigator initiated proposals, and about 30 percent is allocated to what we call requests for applications, or requests for proposals, or contracts, where we identify, ourselves, an area where further investments are needed,

or an action is needed, or new Centers are created. We put those announcements

for competition to the field, and that is how we balance the portfolio between what

comes from the bottom up, and what we want to get accomplished. I am sorry, I

missed that.

Ms. WILSON. I will be interested in pursuing that, as we move along here on reauthorization. And finally, I just ask for your thoughts on how to structure a system

to give access to research, and whether you think it should be public, or only to

medical practitioners. Should it include the successes as well as the failures? What

are your thoughts on how you would pursue this?

Mr. ZERHOUNI. This is a topic that we discussed entirely with NIH Directors as

well as scientists, and it is a very major component of the Roadmap for Medical Research, where in fact, we think that we should make investments in information

technology that would be accessible at the community level. We think that we need

to train community practitioners in research methods, and have a core of 50,000

community practitioners that would have access to our data base, called

clinicaltrials.gov, where we are listing about 14,000 clinical trials. I think we need

to enhance the ability for us to link those trials to the results of those trials.

So my view is more openness, more transparency, more access, to community physicians in particular, because chronic diseases are seen in the community much

more so than they are in academic health centers. And we have an initiative, which

will start this year, called Clinical and Translational Science Awards, which we are

going to announce at the end of August, September.

Mr. DEAL. Ms. Eshoo, you are recognized for questions.

Ms. ESHOO. Thank you, Mr. Chairman, for holding this very important hearing,

and welcome, Dr. Zerhouni.

This is a very large undertaking. I have been in the Congress, this is my thirteenth year, and I am always thrilled when we get to reauthorize NIH, which I always like to refer to as the National Institutes of Hope, and I think that is the way

the American people view the NIH, and it is in that spirit that I ask the following

questions.

First, on transfer authority. This transfer authority is thought to allow you, the

Director, and succeeding Directors, more flexibility to run projects and to streamline

the budget decisions, but of course, we don’t want flexibility to undermine any accountability. And I raise this because last year, broad transfer authority was given

to the NASA Administrator, and I think with devastating consequences. I have a

major NASA Ames, maybe it is good that we are the science hearing room—someone

may come off the walls on this. I have a NASA facility in my district, NASA Ames,

right in the heart of Silicon Valley, and we saw that budgets were being realigned

not to spur progress and development, but to cover funding shortfalls in other areas.

So it was—that transfer authority was being completely, I think, misused, and I

know that there isn’t anyone here that wants to see transfer authority misused.

What would you suggest that could be built into the reauthorization, with these proposed changes, that would not allow the NASA, you know, the—what I just described happening at NASA, to happen within the NIH?

I want to ask my questions, then you can answer. I mean, I agree that NIH scientists are, by and large, more equipped than Congress on where—maybe so, you

know, as a partner, on how best to spend the money, where it should be directed.

But I am concerned that scientists would not have any kind of role in the transfer

authority. I think when the—let me just summarize it by making this observation.

I think NIH works best when it is collaborative. I don’t think it was ever meant

to be an institution that has such a powerful Director that there is only one conductor of the orchestra. You have to have someone that leads, but I do think that

the collaboration needs to be built, and so that it is enjoyed across the board. As

26

you explained, I mean, we have entered a new era. So this transfer authority business is a bit troubling to me, if it is not handled right.

And I have concerns that dividing the NIH Institutes and the Centers into two

categories will not necessarily make NIH function more effectively, or improve Congressional oversight of appropriations. And on that key word of, in terms of appropriations, I know it is a tough call for you to make, but you know what the needs

of the agency are. I am highly skeptical of doing reforms anywhere, when they are

meant, they are really—it is really dressing the issue up to cut or to not fund properly. And you know, one doesn’t take the place of the other. In fact, reforms, many

reforms can’t be carried out unless you have the necessary resources. I see where

the FDA is having a very tough time. FDA has not been funded properly by the

Congress, and yet, we have so much that we expect from the agency. So if we are

going to live up to National Institutes of Hope, and the changes that are afoot, what

would you instruct us about transfer authority, so that it is what it should be, and

not what I described happening in another agency.

And also, on the organization of Institutes, you know, there was one that I helped

to found. I don’t know if it is—with this plan, it is going to be wiped. I mean, I

have had people come to me and say it is working very, very well, the Biomedical

Imaging and Bioengineering Institute. So if you would comment on my observations

also my questions, I would like to see a good, healthy appropriation for NIH. It is

only to help to make the changes, but we have to—this century is going to be the—

is going to be known, I believe, as the century of the biomedical changes. And if

NIH is not embraced by the Congress, in terms of an appropriate appropriation,

then it is going to be—we are going to be talking about out of both corners of our

mouth.

So take it away.

Mr. ZERHOUNI. Well, very important points. I think the——

Mr. DEAL. You have 30 seconds to respond.

Mr. ZERHOUNI. Okay. That is——

Ms. WILSON. He can respond—for the committee as well.

Mr. ZERHOUNI. Yes, I can certainly respond, but I don’t think——

Ms. WILSON. They are serious questions.

Mr. DEAL. Just looking for the question mark.

Mr. ZERHOUNI. As a Director I think it is important to remember what I said before, and that is, it is the balance that is key. A dictatorial counselor authority

wouldn’t work, and I would like to just read, I think, one of the recommendations

of the IOM report, which captures what I think is trying to be accomplished here.

‘‘The Director of NIH should be formally charged by Congress to lead a trans-NIH

planning process’’—everybody is at the table—‘‘to identify major cross cutting issues

in their associated research.’’ That is collaboration, because think, not having any

such authority removes the accountability of the Director to be able to direct the

agency to what it needs to do. So there is a balance between the two. The question

is where you find that balance. And it does instruct the Director to present the scientific rationale for trans-NIH budgeting to the relevant committees of Congress, including a proposed target for investments in trans-NIH initiatives. So it is not a

transfer. It is a common fund for common good, for common needs. That is the concept. And I don’t think it should be deviated from that, provided we put the right

checks and balances and transparency in it. That, I believe, is needed by the NIH.

Mr. DEAL. Dr. Burgess.

Mr. BURGESS. Thanks, Mr. Chairman. I will be glad to yield to the full committee

chairman, if he——

Chairman BARTON. If the gentleman doesn’t mind, I appreciate that.

First, Dr. Zerhouni, thank you for testifying today, and thank you for you and

your staff’s efforts working with us the last year, as we have worked with the stakeholders to come up with the legislation, the draft legislation, that we are looking

at today. I want to let the committee know that this is a very high priority for me

as chairman. If we wish to reestablish the authorizing committees in a meaningful

way, when overseeing the agencies that we theoretically have jurisdiction. Under

the current environment, we haven’t reauthorized NIH in 12 years, and in all—to

be totally true about it, most of the oversight that is being done is being done by

the appropriators. So this effort, while you can argue with the specifics of the draft,

is an attempt to reassert the jurisdiction of the authorizing committees in general,

and the Energy and Commerce Committee specifically over one of the more, if not

the most, one of the more important agencies in the Federal Government.

We have—as well as we all know, we have doubled the budget of NIH, but we

have not done anything to try to help their management structure, or help them

come up with a mechanism for allocating all these new grants and funds that we

have provided them. Nothing in the current draft legislation in any way denigrates

27

the peer review process, the two step solicitation, the grant process at NIH. Nothing. We keep our hands off of that. We are not trying to micromanage. What the

draft does do is collapse the 26 line items to four, No. 1, give the Director, in this

case, Dr. Zerhouni, more direct authority, by empowering him, and enlarging the—

his direct discretion, and then two, creating this trans-NIH fund, that is multi-agency with NIH, and give it real budgetary authority, and real dollars, so that as we

have these cutting edge ideas come forward, they are looked at across the NIH, concurrently, as opposed to individually within each of the 27 Institutes.

I think that is a very good idea. So my first question to you, Dr. Zerhouni, the

general concept of going from multiple line items, in this case 26, down to a more,

a smaller number, in this case, four, at least in approach, do you support that? If

you don’t maybe support the exact numbers, do you support the principle?

Mr. ZERHOUNI. Again, I think, as I testified while you were busy with the other

committee, Mr. Chairman, I believe that the approach, the conceptual approach you

have taken in bringing functional integration, through the mechanism of identifying

what is the function, relative to the structure is, in my view a good approach. The

details, obviously, of how you implement that on the ground, and how do you play

that, it is obviously something we need to work on. But I think the fundamental

concept, that the agencies become more complex and larger, and needs to be more

efficiently managed through a transparent process that makes people have a common good, a common fund for a common good, overall, this is, in my view, a good

contribution to the agency.

Chairman BARTON. What about the line item that we would create, that is transagency, that we give direct authority, with a discrete amount of money, that it

would allocate funds across the different Institutes.

Mr. ZERHOUNI. My comments to that are, Mr. Chairman. I think you need what

I call an opportunity fund. When something comes up that is actually critical, you

need the ability to house it somewhere, so that you can implement it quickly at the

time of the budget request, and that it be authorized. So that is what I call the opportunity fund.

Then, I would say that it is important to have a trans-NIH fund of some sort,

called, what I call the common fund, where everybody is incentivized to come

around the table and discuss, without being afraid of, essentially removing from

their own specific mission resources, because they are mandated by the authorization language to say you need—you shall come together, and you shall identify what

is cross cutting, and what needs to happen. So the authority for having an opportunity fund is important, because you never know what comes up. For example, biodefense came up, and we need to react to that.

A trans-NIH fund is certainly a necessity, and some transfer authority. It

doesn’t—if you have those two, you don’t need large transfer authorities, because

they are different in nature. Transfer authority is post facto. A trans-NIH fund is

prospective. So I think the combination of these three is really what would make

the agency work well.

Chairman BARTON. My—I see my clock has expired. I want to ask one more question. As we put the draft out for review, there appears to be a lot of concern about

where we would set the baseline, the first—if we—if this bill were to become law,

where we would set the baseline. Now, my preference would be that the first year,

if this bill were to become law as-is, the baseline for each Institute would be whatever the funds that it received in the prior year. So we would guarantee every Institute, you know, that—100 percent as the baseline, and then, we would start from

there, and you could go up, and—or they could go down, but the very first year,

every Institute would be held whole, and then we would begin this internal review

and internal competition, and with your discretionary fund, and the trans-NIH fund,

in terms of the first year’s baseline, is that your view, too, that each Institute would

start at 100 percent of last year’s funding?

Mr. ZERHOUNI. Well, clearly, as you know, the process of science is not something

you can do over 3 months, stop, and start again. So it would be very important to

make sure that you don’t disequilibrate the system, I mean, the agency does work

relatively well. To the extent that you—and I would certainly echo what you just

said. I mean, it would be very important to preserve the, you know, the momentum

that many of these Institutes and Centers have undertaken. What I think is important, also, is to realize that the—depending on how we—you technically settle on

what is common fund, what is opportunity fund, what is—then, the answer will affect, obviously, what you wish to accomplish through that mechanism of putting, I

think, a floor.

I think it depends on that planning process.

Chairman BARTON. Okay. And I want to thank you, Dr. Zerhouni. I also want to

thank the chairman of the Science Committee, Mr. Boehlert, for allowing us to use

28

his hearing room, the Science Committee hearing room, so that we could continue

our markup at the Energy Conference downstairs. And if we have energy conferees

here, not to name names, but Mr. Stupak and Mr. Bilirakis, to name a few, we

are—and Mr. Wynn, we are reconvening in 10 minutes downstairs.

Thank you, Mr. Chairman.

Mr. DEAL. Mr. Wynn came in late. We are still confused as to why he is sitting

over here, Mr. Chairman.

Ms. DeGette, I believe you are next.

Ms. DEGETTE. Thank you very much, Mr. Chairman.

Dr. Zerhouni, we have been told by the leadership of this committee that what

they are really trying to do with this NIH reauthorization bill is to look at the organizational structure, and see if there are ways—in a bipartisan manner, that we can

reauthorize the bill by looking at the structure, and looking at some of what I think

are your very wise suggestions. I agree with that approach for the most part. I

think—I mean, I have many fabulous pieces of legislation which are bipartisan, that

I would like to see included in this bill, but I am going to try to work with the leadership. But there are some questions I have been sitting here mulling over, listening

to the testimony, and listening to the questions of my colleagues on the panel, and

I am wondering if you can comment a couple of these. It is not about do we need

more research for this or that, or—tempting as—though it may be, stem cell research.

Instead, I was thinking about when you talked early in your testimony, and it

is this slide here, which your staff kindly provided me with, the key authorities that

the NIH has, prioritizing research, mandating biomedical research, providing grantmaking authority, mandating peer review, mandating training, mandating dissemination of information, mandating human subject protections, and mandating the solicitation of public advice. Do you think all of those areas should be included in a

reauthorization of the NIH?

Mr. ZERHOUNI. Yes. I think those are the basic authorities, and they have served

NIH very well.

Ms. DEGETTE. And I would agree with that. But really, in your view, when we

do this reauthorization in the committee, we should try to work in a bipartisan way

to look and see if the NIH current mandate is adequate in all of these areas, and

whether it can be beefed up or expanded or improved, correct?

Mr. ZERHOUNI. The privilege of the committee, absolutely.

Ms. DEGETTE. Okay. The reason I ask that is, I have a particular interest, which

you know. In this list of items, in the human subject protections, and as you know,

Dr. Zerhouni, I have been working previously for many years with Jim Greenwood,

who was the previous chairman of the Health Subcommittee, and also, I have talked

with Mr. Barton and other members about human subject protections. I am wondering if, in the draft legislation, you or your staff expanded the human subject protection authority that the NIH currently have, as—or have you addressed this at

all in the draft? I haven’t had time to really delve into it.

Mr. ZERHOUNI. Not to my knowledge, but I certainly will check. I have not personally focused on that issue, but certainly, we would be more than happy to share with

the committee staff what the status of human subject protection is, and—in the context of what I know you are interested in.

[The following was received for the record:]

The NIH has a long-standing commitment to the protection of human subjects of

research that dates to the first formal policies it developed for its intramural program when the Clinical Center opened in 1953. Since then, through Congressional

directive and Executive initiative, the agency has developed a comprehensive network of standards and requirements so that NIH-sponsored research, both intramural and extramural, meets the highest levels of human subjects protections.

The legal authority for NIH oversight of human subjects protections in research

supported or conducted by the NIH derives from the Public Health Service Act,

which at 42 USC 289 directs the Secretary of Health and Human Services to establish oversight of research conducted or supported by HHS and its agencies. In accordance with this legal authority, research supported or conducted by NIH is subject to federal human subject protection regulations, known as the Common Rule,

found at 45 CFR part 46, subpart A. These regulations require informed consent

and IRB review. HHS regulations that specifically concern protections and considerations for pregnant women, fetuses and in vitro fertilization, as well as prisoners

and children can be found at 45 CFR part 46, subparts B, C, and D. These regulations are referred to as the ‘‘Common Rule’’ because the federal government, in June

1991, published them as a common policy for federal agencies conducting or supporting research with human subjects. Today, it governs seventeen agencies and

29

most federally-supported research. Additionally, when NIH-funded research is regulated by the Food and Drug Administration (FDA), it is subject to FDA’s human

subjects regulations incorporated at 21 CFR parts 50 and 56.

NIH has measures in place to help ensure that NIH-funded clinical research complies with the ethical guidelines and regulatory requirements for research involving

human subjects and that the rights and welfare of human subjects participating in

NIH funded studies are protected.

For the NIH intramural program, a distinct office is charged with helping intramural investigators understand and comply with ethical and regulatory requirements for research involving human subjects. In the extramural program, NIH has

regulations and policies in place to help NIH-funded clinical research comply with

the ethical guidelines and regulatory requirements, including 45 CFR part 46, for

research involving human subjects.

Pursuant to its authority to set the terms and conditions for research that it

funds, and consistent with the requirements of 45 CFR part 46, the NIH has implemented specific requirements for the protection of human subjects in research that

it funds or conducts (see generally 42 CFR part 52). These include:

• A requirement that applicants or offerors describe and justify the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the

research to the subjects and others, and the importance of the knowledge gained

or to be gained;

• The evaluation of proposed human subjects protections by peer reviewers and

NIH staff, and appropriate resolution of human subjects issues before the study

can be initiated;

• Confirmation that the institution has a current Office for Human Research Protections (OHRP) ‘‘Assurance’’ on file attesting to its compliance with 45 CFR

part 46;

• Certification of review and approval of the research by an Institutional Review

Board (IRB) registered with OHRP under the institution’s Assurance.

• Education in the protections of human subjects for research study personnel designated as ‘‘Key’’ to human subjects research so that they understand the underlying philosophy and specific requirements of human subjects protections

when engaged in clinical research; and

• A plan for data and safety monitoring for all NIH-funded clinical trials; the NIH

policies specify that the level of monitoring should be commensurate with the

risks and the size and complexity of the clinical trial. For certain types of studies (phase III and many multi-center trials), the monitoring must involve a

group of independent experts called a data and safety monitoring board

(DSMB). The role of the DSMB is to review accumulating safety and outcome

data in order to help ensure the continuing safety of current trial participants

and those yet to be recruited.

These requirements are included in the NIH Grants Policy Statement, which is

a standard term of award for grants and cooperative agreements. These requirements are also incorporated into research contracts. An NIH Institute or Center also

has the authority to include additional conditions on the award for specific studies

(see 45 CFR part 52.9). Also, because of special risks and societal concerns, trials

involving human gene transfer that are conducted at or sponsored by institutions

receiving NIH funding for recombinant DNA research must be registered with the

NIH. Investigators responsible for those trials must report adverse events and other

pertinent information to the NIH, as outlined in Appendix M of the NIH Guidelines

for Research Involving Recombinant DNA Molecules.

Ms. DEGETTE. Yes, because a couple of things I am interested in

with the legislation, I am interested in, for example, the common

rule, which now applies in all research that is funded by the NIH,

but does not necessarily apply in other types of research. Am I correct?

Mr. ZERHOUNI. I am not totally briefed on this, and——

Ms. DEGETTE. Okay.

Mr. ZERHOUNI. [continuing] current, but I think you are right.

Ms. DEGETTE. And I am wondering if this might be an area that

we could explore in a bipartisan way, beefing up the application of

the common rule more broadly, into research that is either directly

or indirectly affected by the NIH activities.

30

Mr. ZERHOUNI. Be happy to, you know, to work with the

committee——

Ms. DEGETTE. Okay.

Mr. ZERHOUNI. [continuing] and the staff, your staff, to look at

that. Obviously, the Office of Human Research Protection at the

Department also has jurisdiction over that.

Ms. DEGETTE. Exactly. Right.

Mr. ZERHOUNI. So you have to look at that issue.

Ms. DEGETTE. Okay. But that is certainly a topic that you think

would be appropriate in the NIH reauthorization bill. Thanks, Doctor, and I yield back.

Mr. DEAL. Thank the gentlelady. Dr. Burgess.

Mr. BURGESS. Thank you, Mr. Chairman.

Dr. Zerhouni, when you were here earlier this year, I think one

of the things that came up was the—when we restructured the intelligence agencies last year, one of the big discussions around

town was if you don’t have the budgetary authority, then you don’t

have the authority.

Do you feel that this reauthorization that we are doing currently,

does it provide you with the budgetary authority that you need in

order to exercise the appropriate authority over the NIH?

Mr. ZERHOUNI. I think the important component of the reauthorization is this ability for the Director to have an instrument by

which all of NIH comes together, for at least a small portion of the

total budget, and looks at what I call the glue areas, the synergy

areas. That is an important institutionalized process that needs to

happen for any complex agency. That would provide that.

In terms of budget area, currently, obviously, the Director can always make an administration budget, and through interaction with

the department and OMB, present a budget to Congress. That authority is there. But typically, what happens is everything goes in

lockstep, and the reason it goes in lockstep is because of all of the

stakeholders and different pressures and programs that you have,

unless there is an emergency, or something that changes the equilibrium. What I am talking about is instead of having this, is to

look at a small layer of the budget, and plan it together, not dictate

or direct it. I don’t think the NIH is an agency—it is a knowledge

organization. You really need to manage it according to that.

So I think the reauthorization will provide marginal budget authority for a very specific purpose, but overall, the budget authority

in the current authorization does allow you to make some marginal

changes, but not a lot.

Mr. BURGESS. I must admit, when I first looked at that organizational chart that you showed us early in the year, and knew that

we were coming to this reauthorization, my feeling was that there

would be significant consolidation between the various departments, and I guess I won’t say that I am disappointed that there

is not some consolidation, because after having been onsite, and

watched some of the great work that you do, I realize how little

Congress should, in fact, meddle in the system that you have. But

do you feel that there is enough along the lines of consolidation in

the organizational chart that you maintain with this reauthorization?

31

Mr. ZERHOUNI. I think this allows for a greater degree of functional consolidation that is not there today. I don’t think it allows

for structural consolidation. I think structural consolidation does

happen over time, as science will—changes. I think a reauthorization, in my view, should be done regularly. It shouldn’t be a one

time event every 12 to 15 years. So I think we should really look

at this, and see how it works, and adjust in 3 years time. I don’t

think this is an impractical proposal, but I do believe you need to

show that you have the mechanisms of functional integration, before you can go ahead and destroy structure, and combine structures in a way that may not be productive.

Mr. BURGESS. The—Ms. Wilson, who was here a minute ago,

talked about the ability to get information to the public, and I must

admit, after 20 odd years in clinical practice, I did not know about

clinicaltrials.gov. Maybe there is an opportunity there to do some

public service announcements to medical societies across the country. I thought I saw the AMA here earlier today. That would be,

I think, a good thing, because I can remember times, being in the

treatment room and being absolutely baffled about what do I do

next. It would have been great to know that I could have gone online and gone to clinicaltrials.gov, and gotten that rare cucumber

virus tended to.

And then, finally, I just can’t help myself. What do you see on

the horizon, looking over the horizon, as some of the new scientific

areas of study that your organization may be working on in the

near future?

Mr. ZERHOUNI. Dr. Burgess, you should see the progress we are

making. Every month, there is a new discovery, a new breakthrough. Recently the National Cancer Institute reported on a research study that showed that by looking at 16 cancer-related

genes, in women who have breast cancer sensitive to estrogen hormones—you know, in the past, we had about 100,000 women with

that, and all of them underwent surgery and chemotherapy. By

looking at that—those 16 cancer-related genes, you can see that

70,000 of these women will not benefit from chemotherapy, whereas the other 30,000 do. So that research is going to completely

transform the way we practice medicine in the next year or 2, and

we will save about $8,000 per year of treatment, because we will

avoid chemo, unnecessary chemotherapy. And I think that is the

trend. We—a month before that, we reported in Science and PNAS,

three of our grantees discovered a gene for age related macular degeneration, which will affect 7 to 10 million Americans over time,

that will lose vision because of this. We never knew what the cause

was until this research, but it has to do with a blood protein called

Factor H, and no one had any clue that this could have come from

not your eye but your blood. So this is a breakthrough that is going

to make it possible for us to prevent blindness in the aged population. The acceleration and the momentum that I think we have

been able to demonstrate with the funding that you have provided

us is, in my career, remarkable, my own personal experience. I

have never seen such a rapid fire of discoveries that can really

change the way we practice medicine.

Mr. BURGESS. I appreciate that. Could you give the committee

just a little flavor of what is the magnitude of scientific throughput

32

that is required to come up with one of these genetic determinations?

Mr. ZERHOUNI. I see—I can see you really enjoyed the briefing,

sir. Basically, that is the key. The key, for example, the cancer research, they looked at 250 genes in thousands of patients, put that

into a large data base, analyzed the data base through a high

throughput system, come down on to 16, then did trials on thousands of women. So it really is a scale and complexity that required

more than the NCI itself could do, but multiple collaboration. So

that is the trend, interdisciplinary, collaborative, large scale, but

yet, still, coming from the scientists, and bottom up, rather than

control and—command and control.

Mr. DEAL. Ms. Baldwin, would you defer to Mr. Stupak. He is

just dying to get back to the conference committee, I can tell. I will

come back to you, if you will do so. Mr. Stupak.

Mr. STUPAK. Thank you, and thank you, Ms. Baldwin, for yielding.

Dr. Zerhouni, you mentioned that the need to ensure

clinicaltrials.gov is accessible as possible, and that results of trials

are also accessible as possible. Do you support the making the results mandatory, having them published?

Mr. ZERHOUNI. Basically, we do believe that it is important to

connect clinicaltrials.gov to what we have been trying to do

through public access publishing, so that any report that comes out

in the public domain be linked, so that when someone looks at

clinicaltrials.gov, they know what that trial, what the results of

that trial eventually were. So I think we are in favor of more transparency and more reporting, and more registration of all trials. The

issue of whether or not you can do reporting on the fly about adverse events or other things, that needs to be looked into, because

it goes beyond our jurisdiction. That is an FDA issue, but yes, we

are in favor of trials being connected to their results in some fashion, and accessible to the public.

Mr. STUPAK. Do you have subpoena power to information that

you might find interesting in these trials?

Mr. ZERHOUNI. No, I do not.

Mr. STUPAK. You talked a lot about the fingers and the palm of

a hand, and how do you get the information you need from these

trials that raise a flag with you, if you don’t have any——

Mr. ZERHOUNI. If it is a trial that is——

Mr. STUPAK. Yes, I am sorry. Enforcement power.

Mr. ZERHOUNI. If it is a trial that is funded by NIH, we have,

obviously, the mechanisms to look to what we call a data monitoring and safety board, which is an independent board that looks

at what the investigators and what we are funding. That is how,

for example, we reported on the issue of Celebrex in a trial of the

National Cancer Institute, and other trials that we were looking at.

So for NIH funded trials, we have authority——

Mr. STUPAK. Well, how about non-NIH funded?

Mr. ZERHOUNI. With non-NIH funded trials, we have no authority. We are not a regulatory agency. The FDA does.

Mr. STUPAK. So you may be aware of clinical trials that may be

detrimental to human health, but if they are not published, you

33

really can’t have access to them, to check the credibility, or their—

any evidence.

Mr. ZERHOUNI. We have access to our own, and when—and as I

said publicly, our threshold for stopping a trial is, obviously, greater than—I mean more sensitive than others, because we are doing

research, so we never know that there is a defined benefit. The

FDA is the agency charged for regulatory oversight of other trials.

Mr. STUPAK. Right. Well, as I said in my opening, both you and

the FDA have this responsibility to make sure we have sound clinical trials to protect the health and safety of the American people,

but neither one of you have any kind of subpoena power, so how

do you enforce it? What——

Mr. ZERHOUNI. NIH——

Mr. STUPAK. Well, take Celebrex. You mentioned it yourself.

There were other trials out there you knew of, but you didn’t have

access to them, because they weren’t your own. So how do you obtain that information?

Mr. ZERHOUNI. NIH does not have subpoena power, but I am not

an expert on the regulatory——

Mr. STUPAK. FDA doesn’t either—that is fine.

Mr. ZERHOUNI. I think that is—I haven’t thought about that

question, of how you connect the enforcement powers with the oversight powers. I would be happy to come back on record for you.

[The following was received for the record:]

NIH has access to safety information for the clinical trials we fund. In addition,

NIH policy requires data monitoring in all clinical trials and, for certain types of

studies, depending on stage, level of risk, design, and organization, the monitoring

must involve a group of independent experts, called a data and safety monitoring

board (DSMB, see NIH Guide for Grants and Contracts, June 10, 1998 and June

5, 2000). The DSMB’s role is to review accumulating safety and outcome data in

order to help ensure the continuing safety of current trial participants and those

yet to be recruited as well as the continuing validity of the trial.

Safety information on clinical trials funded by the private sector must be reported

to the FDA when those trials are conducted as part of the development of drugs,

devices, or biologics and data is intended to be submitted to FDA for regulatory approval purposes (see 21 CFR parts 312 and 812). NIH does not have direct access

to adverse event information about such private sector trials. However, we work

closely with FDA and are able to factor information FDA makes publicly available

into our own decision-making about the continuing safety of clinical trials we support and conduct. In this regard, our work will be aided by FDA’s efforts to ensure

that established and emerging drug safety data are quickly available in an easily

accessible form. In addition, we have established a working group to help consider

and, if necessary, make improvements in our assessment and response to emerging

safety information from clinical trials or in post-marketing product surveillance that

has implications for NIH clinical studies and study participants. The goal of the effort is to ensure that NIH’s response to such events is timely, coordinated and well

considered.

We are also working on longer term efforts to promote greater transparency and

awareness through enhanced clinical trial registration and access to published articles and results summaries in ClinicalTrials.gov, NIH’s database of clinical trials.

In establishing ClinicalTrials.gov, Congress mandated the registration of all treatment trials subject to FDA regulation, regardless of funding, that address lifethreatening and serious diseases and conditions (see 42 USC 282(j)).

Mr. STUPAK. Sure. It has always amazed me that the—some of

the regulatory agents, like FDA and—not that you are necessarily

a regulatory agency, but when you are responsible for basic health

needs, you have no power to get the information you need to help

make the decisions.

Mr. ZERHOUNI. Except for what we fund.

34

Mr. STUPAK. Except for what we—you fund, right. And while we

wish you had more money, it is not all the money that is going into

research. There is a lot of research out there.

I mentioned in my opening the importance of one program, pediatric research, and the consequences of striking its authorization.

Is there anything else in the committee draft that may have been

stricken that you would like to see? What is missing in this committee draft that you would like to see, besides subpoena power?

Mr. ZERHOUNI. Any special authorities that were removed, you

mean?

Mr. STUPAK. Yes.

Mr. ZERHOUNI. Well, that is—I haven’t really thought about what

was removed that would be of critical importance. I think—I am

not sure what it is that I would—I am just thinking through as—

think, but——

Mr. STUPAK. Sure. Sure.

Mr. ZERHOUNI. Can I get back to you, and look at that, specifically?

Mr. STUPAK. One more, since my time is just about up. How are

we doing on the flu vaccine for next year?

Mr. ZERHOUNI. We, just last week, had the results of the first

phase of our clinical trials. As you know, NIH has gone forward in

developing a vaccine on H5N1, which is the variant of the virus

that we suspect will be the—if it mutates to the point of becoming

transmissible. We have good results. There is a dose response we

know we have a vaccine. Now, we need to go to the other phase,

but we are very, very pleased with the Phase I results.

Mr. STUPAK. Thank you, and thank you, Mr. Chairman, for your

courtesy.

Mr. DEAL. Thank you. Mr. Ferguson.

Mr. FERGUSON. Thank you, Mr. Chairman. Dr. Zerhouni, I apologize. I have been out, as I know a number of other members have

been. So I may have missed if you have addressed some of these

questions.

Mr. DEAL. Well, we have all been here. We have all been here.

Mr. FERGUSON. Yes. You, Mr. Chairman, I know, have been here.

We talked—I talked a little bit about, and you have referred to the

27 fingers—you need the palm. In your review of the draft, do you

feel like we have—the draft adequately addresses your need, as the

Director, or the need of any Director to properly coordinate what

is going on, to provide the adequate palm, if you will, for management purposes?

Mr. ZERHOUNI. I think it is a good draft, and I think we need

to clarify some details. As I said, I don’t know if you were here, I

said 27 fingers without a palm is not a good hand, but a strong

palm with no fingers is not a good hand, either.

Mr. FERGUSON. Right. Right.

Mr. ZERHOUNI. So we need to find the balance between the two,

but I think we are getting there, and I think the committee staff

and the committee draft are going in the right direction.

Mr. FERGUSON. And if you have, obviously, as you are talking

about, some of this, specifics or the details, I am certain that we

will be talking with you further as you have advice or thoughts,

35

input for us as we continue to go through the process. I hope you

will.

Mr. ZERHOUNI. I will certainly do that.

Mr. FERGUSON. Wouldn’t you share that with us? Like Mr. Stupak, I am particularly interested in childhood diseases, as well, and

I think it is—I feel strongly that we need to make sure that our

agencies are really working together properly, and working toward

research on diseases for, frankly, one of our, probably our quietest

constituency is our kids. How do you feel like this draft, and as we

are—the direction that NIH may be heading, and how will that improve your ability, with regard to the cutting edge research, and

translating that research into actual cures, for some of the childhood diseases that we have talked about?

Mr. ZERHOUNI. As you know, the fundamental authority of NIH

allows NIH to do research in every field, including pediatric research. I believe that having an instrument like this division of

program coordination is going to allow all of us to prospectively,

rather than retrospectively or after a lot of lobbying, to understand

what disease process is doing what, to truly prospectively look at

the evolution of childhood diseases of particular concern. I think

that, to me, will be the result of a modern reauthorization bill that

would institutionalize not only the mechanism but the obligation to

look at the landscape of public health for children, or for any other

population.

Mr. FERGUSON. And will further enable the agencies to, and the

Institutes to kind of get out of their silo, to get out of their, perhaps, more narrow, necessarily narrow view?

Mr. ZERHOUNI. Well, I think the Institutes have done a good job

when it came from their specific mission needs. I think we should

really not think that the Institutes have not collaborated. The

Roadmap is a collaboration. What I think I am talking about is

when there is an area of science or public health where no Institute

has either the resources or the expertise, or the ability, if you will,

to look across, and this is where, I think, that would be very helpful.

Mr. FERGUSON. Well, I—these are just a couple of the points that

have been kicking around in my head.

Mr. ZERHOUNI. Right.

Mr. FERGUSON. And I think a number of the points that some of

the others on the committee have raised today are equally important. So I appreciate very much your insights and your advice, and

not only your work at NIH, but as we go through this process, looking to the future, your continued input is going to be very important for us, so we appreciate very much your time today, and——

Mr. ZERHOUNI. Thank you.

Mr. FERGUSON. Chairman, I yield back.

Mr. DEAL. Thank the gentleman. Ms. Baldwin.

Ms. BALDWIN. Thank you, Mr. Chairman.

I have, first, a narrow question, and then some broader questions

on reauthorization. In your testimony, you talked about the mission specific division relating to research around disease or organs

or life stages, versus what has been called the science enabling division, having more cross cutting issues. And I just looked at the

list of Institutes that would be congregated, as proposed in the

36

draft, I noticed that the National Institute of Environmental

Health Sciences, is under the disease, organ, and life stage specific

grouping. I wonder if you could tell me a little bit more about what

is happening in that Institute, so I could derive whether that is an

appropriate placement of that institute, versus the other divisions

that it could be possibly placed under?

Mr. ZERHOUNI. I have to say that you are very observant, and

I—we have been——

Ms. BALDWIN. Well, thank you.

Mr. ZERHOUNI. [continuing] actually, thinking about the NIEHS

being, again, as—if you look at the fundamental definition, does research in NIEHS apply to all organs, all disease, all life stages, and

the answer is yes, so you could think of NIEHS being a cross cutting Institute.

Ms. BALDWIN. We will take—I am sure we will take a closer look

at that, and have greater discussion.

On some broader questions, with the establishment of four specific appropriation line items for NIH, that we have gone over what

those are, I am concerned about the impact that lumping the Institutes and Centers, most of them in two line items, will have, in

terms of pitting them against each other for the available funding.

In a worst case scenario, you would see a competition that would

result in the loss of cross-institutional collaboration and cooperation that we have recently enjoyed. I wonder if you could comment

on that, and talk about ways to prevent the pitting of institutions

against each other, what we might want to have as safeguards in

this legislation to prevent that.

Mr. ZERHOUNI. That is a very good question. The way you structure a reauthorization structure drives culture. Structure drives

culture, and therefore, you can’t really look at that issue in isolation. You really look at the total structure that I think is being envisioned here. There is no doubt that losing the identity of a mission is not necessarily a good thing, so you need to find balance between the two, and clearly, you don’t want to have a zero sum

game that occurs. You really want to, therefore, have what I call

a common fund for common good, for funding when there is a need

to do it. But again, I mean you have programs that sometimes

don’t need to move out of a particular Institute to be coordinated

with another Institute. So to me, the most important thing is to

keep the planning process, the ability to present a logical plan to

Congress, to the—I mean to Congress in general, and the appropriators in particular, that keeps that identity for the mission. Otherwise, what you end up with is no one is responsible for anything.

So you need to strike that balance between the two.

Ms. BALDWIN. Are you comfortable with legislation that places a

limit on the number of Institutes in each division? Right now, I

think they are looking at 15 in the mission-driven, and nine——

Mr. ZERHOUNI. There is no doubt that, you know, the way Institutes and Offices and Centers have been created has been, I

wouldn’t say haphazard, but frankly, driven by factors other than

pure science. I do believe that, you know, there is a particular law

in—that every time you add one, you double the complexity, and

every time you add another one. I think it is not a good idea to

have so many structures, and I do believe we need to have a limit,

37

and if anything, think about reorganizing. I was just reading the

New York Times this weekend, and General Electric went from 11

divisions to six. And obviously, it is a completely different environment, completely different, but we do need to have a limit to the

number of direct reports and units that are independent, that duplicate their own administrative structures and so on. So yes, I

think every observer, including the IOM, by the way, would say

you need to be very careful in adding any. I think we should subject all of this to a public process, as recommended by the IOM, but

I do believe that limits are a good thing. If—we need to have the

discipline of recognizing a mission, but not at the expense of complexity of management, and unwieldiness of the agency.

Ms. BALDWIN. Dr. Zerhouni, I see that amber light, which means

my time is almost done, in fact, I think it is done, but there are

two questions that I want to pose, and you don’t have to answer

right now. They are both following on questions previously asked

by Mr. Waxman and Mr. Brown.

First, there is the blank by the authorized appropriation level.

Any guidance you can provide us, in terms of how we should be

considering opportunities as we deliberate over what the optimum

rate of increase for NIH is appropriated, and second, following up

on Mr. Waxman’s questions, whether we should have specific language in this draft, or in the final bill, for the next Director of NIH,

who will be a political appointee, to direct them in terms of composing the advisory committees and the institutes?

Mr. ZERHOUNI. I will submit my answer in the record.

Ms. BALDWIN. Thank you.

Mr. DEAL. Thank the gentlelady. Mr. Buyer.

Mr. BUYER. I want to cover a couple of questions. One, in particular, that deals with your Roadmap, and a followup off of Mr.

Ferguson’s question that he had to you about how this legislation,

will it really permit you to implement your Roadmap? And so that

I can understand that better, I think anyone that wants to take on

an organization like—that you have—functional consolidations of

an organization, to integrate activities, to meet strategic goals

based on priorities, that is noble. I—that is your job. That is what

you want to be able to do. And as I was listening to you testify,

I was thinking about a couple years ago, you came up, and you testified about your Roadmap. A lot of us got pretty excited. I remember asking you a question about sexually transmitted diseases in

America, and I was pretty stunned—correct me if I am wrong, but

I thought your testimony was that there are 80 million Americans,

is that about right? Or 65 million?

Mr. ZERHOUNI. Sixty-five million, growing by 4 million a year.

Mr. BUYER. Wow. Sixty-five million Americans have been infected with a sexually transmitted disease. If you actually—take of

our population of 295 million people, and say of that population,

then, what is the highest in sexual activity, you are almost looking

at a one in three, one in four perhaps.

Mr. ZERHOUNI. This is—lifetime, yes.

Mr. BUYER. Yes, in a lifetime, have dealt with a sexually transmitted disease. And the reason I remember that is because you,

then, said Congressman, this is an epidemic. All right. It is an epidemic. I would think that is an epidemic. If you think about it, our

38

society, and this is a problem that—it is sort of the problem in the

closet. It is sort of the problem in the basement, a problem that nobody really wants to talk about somehow, until we have to deal

with it. So I look at this, and you could pick a disease. It doesn’t

have to be a sexually transmitted disease, but I brought that up,

because I remembered you talking about it, and I look at you now

trying to do this consolidation. You have got your Roadmap, and—

so my specific question for you would be can you give us some actual examples from your experience on how the current individual

Institute and Center-oriented structure of NIH, or limited authorities results in missed opportunities, or significantly impeded your

ability to respond to opportunities and public health challenges,

such as the one that you called the epidemic?

Mr. ZERHOUNI. Right. That is a very good question. You have

seen the example of the Roadmap. The Roadmap was not designed

to address any particular public health challenge—it was really the

first time that all Directors said, ‘‘We really need to do better in

cross-investment.’’ So they came together, and if you look at, I

think I have this—this is the investment of the Roadmap.

[The following was received for the record:]

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Mr. ZERHOUNI. We decided to have three topics, pathways to discovery, research teams, clinical research, things that we identify as

gaps in our investment, and commit to a 5-year process. Now, at

the time, funding was a lot easier. It is about 1 percent of the NIH

budget, over time. But when you were done with this, what you realize is that you hadn’t been necessarily responsive to obesity, for

example. So the next year, we asked Dr. Allen Spiegel, from the

National Institute of Diabetes and Digestive and Kidney Diseases,

Dr. Nabel from the National Heart, Lung and Blood Institute—at

the time, Dr. Lenfant, to come up with a trans-NIH plan on obesity. That is how it works, but you know what? We never really

had the mechanisms or the idea of having a process that would be

prospectively looking at that. And I have been trying to instill this

in my interactions with the agency, because I do believe, from my

previous experience in the private sector, that science requires that

now. It is too complex, but you need to have a crosscut of exactly

what you are doing.

So what other opportunities? Neuroscience. If you look at the disease burden in patients from 25 to 44, mental health becomes the

major problem that affects the population, drug and addiction, alcohol abuse, behavioral problems, neurodegeneration, and mental

health. You take those five, it is a $500 billion healthcare cost. So

we decided to have a Neuroscience Blueprint this year, which we

are presenting in 2006, but guess what? You couldn’t fund it, because there was no prospective mechanism by which you would say

here is a set aside fund. This is our opportunity fund. This is our

common fund. Let us just make sure that every time there is an

emergency out there, that we react to it. So the question you are

asking is, this will provide you a mechanism to look at public

health burden, what is rising, what is not rising. We knew about

obesity all these years, but we really didn’t have a mechanism to

A, plan for it, and then, allocate resources. The mechanism that

usually happens is an office is created in law, like the Office of

AIDS research, because there is a public health emergency, or this

is more language that is put in the bills, because a particular disease process or constituency wants that served. I think having this

process would continuously allow NIH to be responsive, nimble,

and proactive.

Mr. DEAL. Thank the gentleman. Mr. Rush.

Mr. RUSH. Thank you, Mr. Chairman.

Dr. Zerhouni, the last time that you appeared before our committee, the question that I asked was what could NIH do to better

promote the inclusion of minorities and women in clinical research,

both as subject and researchers. And can you tell us now how exactly NIH dollars are being used to promote racial and gender inclusion, and also, include in your answer whether or not NIH dollars are being used to promote minorities and women as researchers themselves, and also, included in your answer, would you give

us some idea about how can NIH encourage private sector companies, such as pharmaceutical firms and medical device manufacturers to include minorities and women in their clinical research, as

both subjects and also, as researchers? Can you give me a quick

answer on those, please?

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Mr. ZERHOUNI. Well, first of all, let me say that if you have attended some of my presentations, health disparities is one of our

top five priorities, and remains one of our top five priorities. No.

2, there are two parts to your question. One is what are we doing

in terms of having a scientific workforce, a medical workforce, that

is able to study and research these conditions? Our basic philosophy is that, from the scientific standpoint, it is very clear that the

diversity of those who conduct the research has to mirror the diversity of those who participate in the research as subjects. So we

have this philosophy that to penetrate communities, you have to be

there, and you have an interaction that is constructive with a diversity that reflects that population. That is a challenge, because

when you look at the number of women or minorities in science careers, what you find is difficulties there. I mean, it is an opportunity issue. Young African-Americans, for example, who are very

successful, may not necessarily see science as a maximizing opportunity for their own career. On the other hand, I think NIH has

been consistently proactive in building minority training programs.

The new Center on Minority Health and Health Disparities spends

quite a bit of resources on building the infrastructure for that, and

you can see it is paying off.

The other issue is participation. That is an issue that relates to

the Roadmap, and the concept that you need to conduct research

at the community level. So we funded, for example, the Jackson

Heart Study. The National Center for Primary Care that Morehouse has funded, with 136 community centers, having a presence

in the communities. That is the answer. The answer is you have

to be on that ground, with trained people that are connected to all

the trials that are ongoing, if you really want to have participation.

Mr. RUSH. I want to quickly move to another one of my interests.

A Newsweek magazine that highlights the problem of uncertainty

within the medical profession when it comes to prescribing drugs

for children. According to the article, because drug companies have

not invested in clinical research involving children, apparently, it

is not very profitable, the doctors are basically flying blind with

nothing but speculation when prescribing drugs to children. The results can lead to both inadequate treatment and even death, and

Mr. Chairman, there is an article that I would like to submit for

the record, a Newsweek article that I would like to submit for the

record.

Dr. Zerhouni, what should NIH do to correct this problem, and

what can Congress do to ensure NIH is addressing the problem,

and is the solution including children in clinical trials?

Mr. ZERHOUNI. Well, as you know, the BPCA, the Better Pharmaceuticals for Children Act, mandates that we look and rank all

of the medications that need testing in children, because we do believe that we need, there is a need for making sure that we understand how—what is the dose, what are the side effects, which may

be different. So we have a process through the National Institute

of Child Health and Human Development, that looks at the drugs.

There is a committee that meets at the departmental level, and in

conjunction with the Foundation for NIH and the FDA, essentially

prioritizes the trials that need to be undertaken in particular—

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adult drugs that are used for children. So we have a mechanism,

and I think that mechanism leads to——

Mr. RUSH. Well, how effective is that mechanism? Because we

still have a very serious issue, and a serious problem with children

who are getting inadequate dosage, or maybe too much dosage?

Mr. ZERHOUNI. I know it is, can I get back to you on that, because I know we have about 11 drugs that are being tested, or on

the list of being tested, but I don’t know the specifics at this point.

[The following was received for the record:]

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Mr. DEAL. The gentleman’s time has expired. Ms. Blackburn.

Ms. BLACKBURN. Thank you, Dr. Zerhouni. If you get down to

me, you know you are getting pretty close to the end. I am the only

one left over here.

Just a couple of quick things, and you—Mr. Ferguson and Mr.

Buyer both talked a little bit about your organization, and you

mentioned where you would have put some focus this year if you

had had funding. But I want to go back to something that Dr.

Varmus, who was your predecessor, had said in 2001. He mentioned that he felt like you could add 10 Institutes a decade, and

what I am hearing from you is you probably would opt not to

that—not to do that, but would work within your framework, and

use the flexibility from the proposed legislation to allow you to

meet those needs. Is that a correct understanding?

Mr. ZERHOUNI. Right. I know Dr. Varmus well, and what he was

referring to, what he told me, is that unless we have a mechanism

to prevent proliferation, we will end up with 10 per decade, and

then make the agency less manageable. He has advocated, actually,

consolidation of all Institutes into five Institutes. So he is clearly

one who has been very concerned about the rapid growth of the

number of Institutes.

Ms. BLACKBURN. Excellent, and thank you for the clarification on

that. A little bit on flexibility and collaboration, and let me use, to

make the point, use the SARS outbreak, because I have read that

you all did some research and some work on SARS in 2003. Now,

we are hearing about avian flu, and the possibility of avian flu. So

using SARS as our real life example, and our experience, talk to

me just a little bit about how quickly you were able to put funding

into the Institute for Allergy and Infectious Diseases, and the old

structure, what your turnaround was on meeting the need for research, and then, the new structure, how you would plan to do

that, and if St. Jude’s, which is right in Shelby County, which—

one of the counties I represent—is doing some avian flu work. So

how quickly would the new legislation allow you to respond, and

how would it make it easier than the old legislation?

Mr. ZERHOUNI. Very important points. In the SARS case, we had

invested NIAID, the National Institute of Allergy and Infectious

Diseases, invested in Asia years ago, in having laboratories in Asia,

to, in fact, be our sort of warning stations for flu. We actually

thought it was flu at the beginning. When we identified, CDC identified that this was a different disease, we then collaborated with

CDC, and very quickly, were able to identify the virus. Now, you

are asking what did you then do to develop a vaccine to—for

SARS? The Institute then reallocated resources, because of the doubling, we have built a Vaccine Research Center, which is extremely

capable, so that the fundamental investment was there, and then

the Director of the Institute reallocated dollars within its Institute

to develop the early prototypes of two, and now, three SARS vaccines, one of which is in trial.

In the case of pandemic flu, this is a much larger problem. The

Secretary Levitt has appointed a taskforce that is being coordinated across the government. There is no doubt that we need to be

able to move resources. In the current context, it is not that easy

to do. I can use transfer authority if I need to. It is 1 percent of

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that. We can also, obviously, use a 1 percent transfer authority the

Secretary has, to be able to move dollars in that category. You can

use contracts. So in the case of flu, we have been able—over a year

ago, we knew that there was a risk of flu, to develop a prototype

vaccine, and we have a prototype vaccine. We have 2 million doses,

and it has been tested last—this past few months.

Ms. BLACKBURN. And under your existing structure, how quickly

were you able to do that, and under the proposed structure, how

quickly would you anticipate being able to do that?

Mr. ZERHOUNI. The current structure that is being proposed is

really to be more strategic and proactive in known public health

problems——

Ms. BLACKBURN. Okay. So it would not affect that. One quick

thing, one last question. I like your mission statement, and basically, what it is saying is science in pursuit of knowledge to improve health. So as you look at your mission, and we talk about the

proposed legislation, does the legislation improve your ability to

meet your mission?

Mr. ZERHOUNI. I believe so. I think improvements in our ability

to coordinate and synergize the 27 Institutes and Centers is very

important to science today. If you look at the key elements of

science today, one, it has become interdisciplinary. You need people

from physical sciences, computer science, mathematics, working

with biologists. So they cannot be locked into silos.

Second, the scale of experiments that we do is larger, and there

is—and when I started research, we had three members of my

team, myself and two co-investigators. You go to any scientific

meeting today, or look at a publication in any journal, you will

have 15 collaborators. So collaboration is very important as well.

This means that Institutes and NIH in general needs to be more

nimble and more aggressive in stimulating and incubating these

sorts of approaches, and I think it will do that.

Ms. BLACKBURN. Thank you.

Mr. DEAL. Ms. Capps.

Ms. CAPPS. Thank you, Mr. Chairman, and Dr. Zerhouni, thank

you very much for spending this entire afternoon here with us. I

appreciate your testimony.

In it, you referred several times to the report of the Institute of

Medicine, and I want to refer to the Institute’s recommendation

No. 4, regarding the ability to respond to new challenges, for enhancing and increasing trans-NIH strategic planning, the D part of

that, which designates, or they recommend a percentage of each Institute to be preserved for trans-NIH research. Today, in your testimony, you have spoken several times, and have referred in some

of your responses to questions about a common fund for trans-NIH

research. I would like to give you the opportunity to spell out what

you mean. Do you see this as a standalone pot of money, or is it

sufficient to require, as the IOM suggests, and just elaborate as to

how you talk about that common fund?

Mr. ZERHOUNI. So effectively, you can handle it in, like I said,

in three different ways. I think what the IOM is recommending is

what I call the common fund.

Ms. CAPPS. Right.

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Mr. ZERHOUNI. So in other words, you know that 5 percent of

your budget is going to be not determined by you, as NIH Institute—I mean, as, by an Institute Director, but it will be put in a

common pool, to be jointly planned, jointly decided for, initiatives

that are important, emerging, and so on. That is the common fund

concept.

Ms. CAPPS. I understand. Now, that is part of the—each Institute’s budget.

Mr. ZERHOUNI. It is part of the mission——

Ms. CAPPS. That they are going to set aside for that.

Mr. ZERHOUNI. Yes. I don’t think it is necessary, No. 1, to take

away from the Institutes.

Ms. CAPPS. Right.

Mr. ZERHOUNI. In their base. Second, I don’t think it is necessary

for the Director to have grant-making authority. I think—I don’t

think you need to be grant making. You don’t want to create an

Institute——

Ms. CAPPS. That is what I wanted to really be clear about.

Mr. ZERHOUNI. Right.

Ms. CAPPS. Do you want the Office of the Director, whether it is

you or whoever it is, to have direct grant making authority?

Mr. ZERHOUNI. No. I think grant coordination, resource allocation

decision, planning authorities, to be able to look across and not be

told, well, this is not really your money, it is my money.

Ms. CAPPS. Right. So but you——

Mr. ZERHOUNI. That phenomenon needs to go away.

Ms. CAPPS. But what role would you play, or the Director play,

in this?

Mr. ZERHOUNI. Coordination.

Ms. CAPPS. Just coordination.

Mr. ZERHOUNI. Yes, strategic coordination, just what it says, program coordination across the silos, strategic initiatives, create a

transparent process, that is based on an analytical framework that

is good for analysis, good reporting.

Ms. CAPPS. Okay.

Mr. ZERHOUNI. This is just basically decision support——

Ms. CAPPS. Okay.

Mr. ZERHOUNI. [continuing] mechanism. Not take the money

away, not—nor become, in—a twenty-eighth Institute. I don’t

think——

Ms. CAPPS. Right.

Mr. ZERHOUNI. I don’t think that is a good idea.

Ms. CAPPS. I see. It—and do you have ideas about—is it a permanent set aside of this funding mechanism, or——

Mr. ZERHOUNI. If you don’t make it permanent, you will never

change the culture. They don’t——

Ms. CAPPS. So you are using this as a way of changing the culture, getting at your ideas of responsibility——

Mr. ZERHOUNI. Of the margins, yes, to instill the fact, and the

need to coordinate better for scientific challenges that have become

bigger and larger.

Ms. CAPPS. So I want—I am going to turn to another topic, but

I wanted to make sure—this is something that you really have

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pulled out of the Institute of Medicine report, and you really want

to see that as a focus of the new NIH, as your envisioning it——

Mr. ZERHOUNI. Right.

Ms. CAPPS. [continuing] as being more flexible.

Mr. ZERHOUNI. Well, from my standpoint on the IOM report, this

recommendation No. 4 is critical.

Ms. CAPPS. All right.

Mr. ZERHOUNI. And I support it.

Ms. CAPPS. Okay. Great. Another topic, since I have a little bit

of time left, there—in the draft legislation that the committee is

preparing, there is a new division, the Division of Program Coordination, Planning, and Strategic Initiatives, to oversee and coordinate the offices currently located within the Office of Director, and

so forth. In other words, in a way, you could say a new bureaucracy, but I, you know, I don’t want to cast a negative word on that.

I have heard some concern that creating a new division to carry

out these functions could weaken the authority of the existing Office. It could make for more reporting, when you are talking about

that there is already a lot, and—so can you comment on what you

see as the ideal model for managing coordination and strategic

planning at NIH, since this is such an important focus for the future?

Mr. ZERHOUNI. Again, I don’t think that division should be in

charge of all strategic planning for all missions at NIH.

Ms. CAPPS. Okay.

Mr. ZERHOUNI. That should be left to the Institutes. It is really

the synchronization and coordination that this division should be

doing. As far as the Offices, remember, the Offices were created because there was somewhere, somehow, a need, felt by many people

in the community, including Congress, for better coordination.

Ms. CAPPS. Okay.

Mr. ZERHOUNI. That is why they were created in law. So I think

they should continue their role. They should be coordinated, but

the problem that you are talking about, bureaucracy, is every time

you create a new structure——

Ms. CAPPS. Yes.

Mr. ZERHOUNI. [continuing] you have created a new bureaucracy,

and that is what I think we need to avoid. We need to find ways

of preserving their role and continue their mission. I mean, the Office of AIDS Research plays a very important role.

Ms. CAPPS. Right.

Mr. ZERHOUNI. Look at the authorities of that office.

Ms. CAPPS. Right.

Mr. ZERHOUNI. I mean, OAR looks at the AIDS budget across

NIH. That should be continued.

Ms. CAPPS. Just to be clear, and kind of as a way of giving us

advice on designing this legislation, would existing Offices need to

report to the division? Is there a chain of command here?

Mr. ZERHOUNI. Well, I think the division should be pulling from

their staff, division of the Director. So to me, the Director should

really take a role here, because he or she is accountable. The problem is, if she is accountable, shows up at hearings like this——

Ms. CAPPS. I see.

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Mr. ZERHOUNI. [continuing] when there is a problem, but they

don’t necessarily have the authority to be able to be accountable,

so I think the divisions should be part of the Office of the Director.

Ms. CAPPS. And when you say coordinator, you give a lot of authority to coordinator. I mean, that is—you are saying that is

where your responsibility lies, or the Director’s responsibility.

Mr. ZERHOUNI. That is right. Yes, over a——

Ms. CAPPS. Kind of a bottom line.

Mr. ZERHOUNI. Well, that is—portion of the budget that should

be jointly planned and jointly executed.

Ms. CAPPS. Thank you, Dr. Zerhouni.

Mr. ZERHOUNI. Thank you.

Mr. DEAL. Mr. Green.

Mr. GREEN. Thank you, Mr. Chairman. I ask unanimous consent

to have a statement placed in the record.

Dr. Zerhouni, the current organization at NIH affords the Institute in Cancer, and Center Directors, with a great amount of autonomy in priority setting, Director of the National Cancer Institute is arguably an even greater autonomy, since he has the ability

to take the NCI budget directly to the OMB. This structure has enabled cancer research to develop new therapies, and to make great

strides toward cancer. Under the organization structure proposed

in this draft legislation, would have the NIH Director have sole responsibility for priority setting. While the draft remains silent on

budgetary bypass authority for NCI, do you envision the NCI retaining that authority to go directly to the OMB?

Mr. ZERHOUNI. First of all, the NIH Director should have the sole

priority setting authority. I hope I made myself clear, Mr. Chairman and Mr. Green, that it needs to be balanced. It needs to be

part of a coordinating effort that should not be subject to the veto

of every 27 Institutes and Centers. That is what I mean by the reason to do that, but beyond that percentage of trans-NIH initiatives,

I think the Institutes should retain their fundamental missions and

authorities, and in the case of the National Cancer Institute, I

think it has been very important to the NCI, and to its community,

from what I hear, this authority to go and have a bypass budget

and so on is critical to their mission. So I think it should be preserved, provided that they also participate in the common fund for

the common good.

Mr. GREEN. The draft legislation strikes a number of authorizations that are either expired or never been appropriated. It is clear

from the intent that the bill is to strike expired authorizations of

appropriations, while maintaining authority to carry out these programs. I am interested how the NIH views these authorizations in

setting priorities. For instance, in 2000, Congress passed the Clinical Research Enhancement Act, which included a clinical research

loan repayment program, to encourage investigators with medical

school debt to pursue a career in clinical research. However, during

the Congressional consideration of that legislation, NIH made clear

to us that the loan repayment program needed specific authorization in order to make the program available to extramural researchers—NIH campus. Would the strikes contained in this bill

lead you to discontinue the Clinical Research Loan Program, and

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can you speak to the overall impact, if any, on these strikes to the

NIH continuing the Clinical Research Program?

Mr. ZERHOUNI. That is a good question. I really—this is obviously

a technical issue. I am not clear about the authorities that we

have, but I do know that we do have the authority to do loan repayment in PHS, authority, as I testified. I would—definitely

would like to have my legal people help me with that, and get back

to you on the record.

[The following was received for the record:]

Removal of the ‘‘authorization of appropriation’’ provisions would not affect the

NIH’s ability to conduct clinical research programs, including loan repayment programs, authorized by statute, so long as appropriations are deemed available. The

changes and additions to the authorizing legislation to enable extramural clinical

researchers to apply for loan repayment made by the Clinical Research Enhancement Act were necessary because prior NIH statutory authority only provided for

a loan repayment program for clinical researchers from disadvantaged backgrounds

who agreed to conduct clinical research as employees of the NIH.

Mr. GREEN. Well, the biggest concern I have about that is their

impact on the goal of attracting health professionals to careers in

clinical research.

Mr. ZERHOUNI. Absolutely. I understand very well.

Mr. GREEN. And my last question, Mr. Chairman, the bill contains four broad authorization levels, that authorize appropriation

for individual Institutes or Centers. If this draft bill were to become law, and the Appropriations Committee continued to provide

line item appropriations for individual Centers and Institutes,

would—the result would essentially be unauthorized appropriations. Of course, this scenario happens quite frequently here in

Congress, that we have approved money, but appropriation for

money that is not authorized. Is it your preference to receive four

different appropriated amounts, or would you prefer that Congress

provide individual Institutes and Centers with line item appropriations, and can you speak to that role, that increased transfer authority plays in that scenario? For example, I know you talked

about the certain percentage in—for example, if NIH were to receive appropriations that mirror these four authorization groups,

why is it individual transfer necessary? You are already deviating,

or divvying up the money individually.

Mr. ZERHOUNI. As I mentioned in my previous, I think it is

very—from my standpoint and my experience, I think it is extremely important that whatever we do, we do it progressively, and

whatever happens, we can’t overnight make wholesale changes at

NIH. It is not possible. So whatever the committee eventually decides to do, we need to retain the ability to maintain the momentum, and whatever I am talking about, in terms of transfer authorities, or common fund, or opportunity, however it settles, we

need to really, also, make sure that there is a smooth transition

from State A to State B. And I guess I am being—I am answering

both questions at once.

Mr. GREEN. Yes.

Mr. ZERHOUNI. There is value to making sure that this goes to

that mission, for that amount, and that it doesn’t change erratically from year to year, because we have to maintain these programs over time, and second, I think it is important to understand

the difference between a transfer authority which is post facto, a

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common fund, which is prospective, an opportunity fund, which is

responsive to—and this is where I think we need to have more

interactions with the committee, which I think we have had, and

refine that concept.

Mr. GREEN. Mr. Chairman, since my time has run out, and I just

appreciate, Dr. Zerhouni, for your patience this afternoon. Obviously, there is a lot of interest on both sides of the aisle, because

so many of us are proud of what NIH is doing with all the Institutes, although I understand the organizational chart can be a

nightmare. We just don’t want to lose all the success we have had.

Thank you, Mr. Chairman.

Mr. DEAL. Thank the gentleman. Mr. Engel.

Mr. ENGEL. Thank you. Thank you, Mr. Chairman, Dr. Zerhouni.

I saw, I listened to your presentation, your testimony, and the

slideshow, and I have to say that you make a very good case for

the need for change.

I have two specific questions regarding that that I would like to

ask, but I do think that the slides and your presentation were on

the money. I mean, some of us have some questions about some of

the nuances, but I think overall, I think the vision is a good one.

I want to talk to you first about the Office of AIDS Research.

That has been very much praised as a model for strategic planning

for many years, and for budgeting, because the OAR has the statutory authority and responsibility to develop a comprehensive strategic plan, with input from the NIH ICs, and from nongovernmental scientists, and community advocates, and everyone involved

with AIDS. The OAR director has the authority to move resources

across the different Institutes to address scientific priorities that

may change from year to year, and the draft bill, I think, and correct me if I am wrong, implies that the NIH Director would now,

and I have a quote, ‘‘be responsible for strategic planning and priority setting of all research activities conducted or supported by the

NIH.’’ That is the quote. Lots of people have expressed concern to

me that the expanded authority of the NIH Director could undermine the existing statutory authorities of the Office of AIDS Research provided by Congress, and I am wondering if you could comment on that.

Mr. ZERHOUNI. A very good question. I think there is a tremendous amount, sometimes, of anxiety about any change, so you can

hear, but I think we need to be responsive to that. First of all, I

consider the model at OAR has been a good model. Think about it.

The Director of NIH never had that authority over any part of the

portfolio of NIH. Yet, OAR has it. OAR can look strategically, get

counsel from the Institutes, look at the portfolio, reassign the portfolio. Like, for example, Dr. Jack Whitescarver changed the priority

to vaccines over the past 2 years, because we have now vaccines

candidates we want to try. It is changed to what drugs, at the time;

that was progressive. Likewise, I think it is understandable, and

I think the committee is sort of paralleling my own thoughts, and

the thoughts of the IOM and others, to say why wouldn’t the Director of NIH also have that same sort of OAR type authority over a

common fund—what is wrong with that—without taking away

from the important mission of OAR?

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So my view is that these are complementary, not exclusionary of

each other. I think the NIH Director needs to have what I would

call generic authority over a small portion of the budget, just like

OAR has specific authority over 10 percent of the NIH budget,

which is the AIDS portfolio.

Mr. ENGEL. But you can certainly understand why there would

be some transition.

Mr. ZERHOUNI. Absolutely. Absolutely, and I believe that, as I

said in my slideshow, that those Institutes should retain their

role—I mean those Offices.

Mr. ENGEL. Thank you. My second question is about

translational research. It has been a major priority, obviously, of

the NIH, and I have a very specific question. How would the legislation affect the agency’s ability to promote and conduct

translational research, especially in areas such as research on

Charcot-Marie-Tooth Disorder, which has the potential to translate

into direct benefits for other—research into other

neurodegenerative disorders, such as ALS and multiple sclerosis?

Mr. ZERHOUNI. I think that is a very interesting question, of

what would happen, if the only way this structure will change, if

Charcot-Marie-Tooth is obviously a disease that we are responsible

for, and we have a mission to help. But let us suppose something

new happened in either the therapeutic world, or—and something

that no single Institute could put in place. That new structure

would basically look at that, and potentially, allocate common resources for an emerging area of opportunity that would be relevant

to that disease, but this structure is not dedicated or designed to

serve special purpose outcomes. Diseases, organs, life stages, cross

cutting science, should be primarily done in its great majority by

the Institutes in their missions as specified. The structure should

only be the glue for things that are of common interest to all. So

it may not be relevant to a specific disease, but it could be relevant

to something that is emerging, that is affecting the landscape of

science in one way that may be relevant to Charcot-Marie-Tooth for

that particular case. So sometimes, for example, we have in trial

right now a drug, to potentially be important for ALS. It is an antibiotic. No one knew that it could have a role. Well, reacting quickly

to that would require, perhaps, a discussion, a coming together of

all the Institutes, and say this is something novel, this is something we need to try. That might be impacted at that point.

Mr. ENGEL. Well, thank you, and let me just conclude by thanking you for staying this long, and thanking you for the great job

you are doing. Thank you, sir.

Mr. ZERHOUNI. Thank you.

Mr. DEAL. Dr. Zerhouni, we likewise reiterate our appreciation

for your being here today. I think you can tell the committee has

great interest in what we are doing. By our accounts, some 29

members have spent at least some quality time with us this afternoon, and I appreciate your patience, and if you wish to supplement or add additional information for the record, you may certainly be free to do so.

I would like to also pay tribute to Cheryl Jaeger, who is our staff

person primarily responsible for this major undertaking, and express our appreciation to her for her hard work, as we try to finalVerDate 11-MAY-2000 07:18 Dec 05, 2005 Jkt 000000 PO 00000 Frm 00066 Fmt 6633 Sfmt 6602 22987.TXT HCOM1 PsN: HCOM1
63

ize this product, and to my colleague, Mr. Brown, for his patience

as well.

There being nothing further to come before the committee, this

hearing is adjourned.

Mr. ZERHOUNI. Thank you, Mr. Chairman.

[Whereupon, at 4:40 p.m., the committee was adjourned.]

[Additional material submitted for the record follows:]

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